[{"additional":"","additionalPlain":"","categories":{"commitment":"Full-time, Permanent","department":"AcelaBio","location":"Boston, Massachusetts","team":"AcelaBio","allLocations":["Boston, Massachusetts","New York, New York","Raleigh-Durham, North Carolina","Toronto, Ontario","Newark, New Jersey","Chicago, Illinois","Detroit, Michigan"]},"createdAt":1779724252735,"descriptionPlain":"","description":"<div>\n<div><strong><span style=\"font-size: 16px;\">About AcelaBio</span></strong></div>\n<div>\n<p style=\"text-align: left;\">AcelaBio is a CAP- and CLIA-accredited specialty histopathology laboratory based in San Diego, CA.&nbsp;We deliver anatomic histopathology, immunostaining, digital image analysis, spatial transcriptomics,&nbsp;and biomarker endpoints to pharmaceutical and biotechnology sponsors. Our team is scientifically&nbsp;driven, client-focused, and committed to advancing translational research through rigorous,&nbsp;reproducible methods.</p>\n<p style=\"text-align: left;\"><strong>THE OPPORTUNITY</strong></p>\n<p data-start=\"0\" data-end=\"341\">The Business Development Director plays a key role in driving growth within a designated region or customer segment, helping expand AcelaBio’s partnerships and market presence. This is a highly collaborative, client-facing role that combines strategic thinking, relationship management, and commercial leadership in a fast-paced environment.</p>\n<p data-start=\"343\" data-end=\"770\">In this role, you will identify and pursue new business opportunities, build strong sponsor and partner relationships, develop targeted sales strategies, and lead initiatives that support AcelaBio’s continued growth. You’ll work closely with internal teams and external stakeholders to deliver high-quality solutions from proposal development and client meetings through to bid defenses and contract negotiations.</p>\n<p data-start=\"772\" data-end=\"987\" data-is-last-node=\"\" data-is-only-node=\"\">The ideal candidate is commercially driven, proactive, and energized by building lasting partnerships, navigating complex opportunities, and contributing to the success of an innovative, client-focused organization.</p>\n</div>\n</div>\n<div>&nbsp;</div>\n<div><strong>Positions Available</strong>: 1; Primarily focused on East Coast coverage in North America (Canada/US).&nbsp;</div>\n<div>&nbsp;</div>","id":"8ecac106-9702-4d81-977a-be2fc011199f","lists":[{"text":"About the role:","content":"<div>\n<p><strong>Sales Growth and New Business Development (50-60%)</strong></p>\n<ul type=\"disc\">\n<li>Achieve annual sales target objectives for a defined region and build the client base in new markets.</li>\n<li>Develop and lead client presentations; manage the internal proposal development process including draft proposals, cost estimates, and quality control of proposal documents.</li>\n<li>Support the VP and Contracts team throughout the contract negotiation cycle; lead negotiations for select clients.</li>\n<li>Lead BD marketing activities by attending trade and scientific conferences and collaborating with the Marketing and Scientific team to develop brochures, web content, and presentations.</li>\n\n<p><strong>Client Management and Sales Strategy Support (25-35%)</strong></p>\n<ul type=\"disc\">\n<li>Assist with strategic sales planning and implementation and support geographic or new market expansion planning.</li>\n<li>Regularly meet with existing and prospective sponsors to ensure a clear understanding of AcelaBio’s capabilities and gauge satisfaction levels.</li>\n<li>Partner with the Project Operations team to keep abreast of project updates and milestones to strengthen client relationships with regular updates, address ongoing issues, and manage expectations throughout the project life cycle.</li>\n<li>Maintain CRM system (HubSpot or Salesforce) is updated to ensure accurate, complete and current records for all leads, contacts, opportunities and customer interactions.</li>\n<li>Analyze and report on market trends and competitor offerings; contribute sales and client perspectives when the organization is developing new products, services, or market growth strategies.</li>\n\n<p><strong>Partner and Vendor Development and Support (15-25%)</strong></p>\n<ul type=\"disc\">\n<li>Support Operations teams in identifying and sourcing new vendors in compliance with AcelaBio and industry standard requirements.</li>\n<li>\n<p>Assist with creation, review, and selection of vendor and partner RFPs; lead or support vendor meetings and negotiations as required.</p>\n</li>\n<li>\n<p><span style=\"font-size: 9.0pt; font-family: 'Century Gothic', sans-serif;\">Support the Contracts team with contract finalization and the QA team with vendor qualification requirements; monitor vendor budgets on an ongoing basis</span></p>\n</li>\n\n</ul></ul></ul></div>"},{"text":"About you:","content":"\n<li>Undergraduate degree (Bachelor’s or Honors Bachelor’s) with 5-8 years of related experience; OR college diploma with a minimum of 8 years of related experience.</li>\n<li>Ability to cover EST-based clients&nbsp;</li>\n<li>Science or business degree preferred; industry experience required. Continuous training and professional development expected.</li>\n<li>Proven track record in B2B sales and business development in clinical research, CRO, or a related life sciences services sector.</li>\n<li>Ability to analyze market trends, assess competitor positioning, and translate insights into actionable sales strategies. Strong communication skills across technical, scientific, and executive audiences; experience with proposal development, RFP responses, and contract negotiation.</li>\n<li>Strategic business development with demonstrated ability to grow a regional client base in a CRO or life sciences environment</li>\n<li>Executive-level client relationship management and complex negotiation across multi-stakeholder environments.&nbsp;</li>\n"}],"salaryRange":{"min":86000,"max":143000,"currency":"USD","interval":"per-year-salary"},"text":"AcelaBio - Business Development Director","country":"US","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>\n<div><strong><span style=\"font-size: 16px;\">About AcelaBio</span></strong></div>\n<div>\n<p style=\"text-align: left;\">AcelaBio is a CAP- and CLIA-accredited specialty histopathology laboratory based in San Diego, CA.&nbsp;We deliver anatomic histopathology, immunostaining, digital image analysis, spatial transcriptomics,&nbsp;and biomarker endpoints to pharmaceutical and biotechnology sponsors. Our team is scientifically&nbsp;driven, client-focused, and committed to advancing translational research through rigorous,&nbsp;reproducible methods.</p>\n<p style=\"text-align: left;\"><strong>THE OPPORTUNITY</strong></p>\n<p data-end=\"341\" data-start=\"0\">The Business Development Director plays a key role in driving growth within a designated region or customer segment, helping expand AcelaBio&rsquo;s partnerships and market presence. This is a highly collaborative, client-facing role that combines strategic thinking, relationship management, and commercial leadership in a fast-paced environment.</p>\n<p data-end=\"770\" data-start=\"343\">In this role, you will identify and pursue new business opportunities, build strong sponsor and partner relationships, develop targeted sales strategies, and lead initiatives that support AcelaBio&rsquo;s continued growth. You&rsquo;ll work closely with internal teams and external stakeholders to deliver high-quality solutions from proposal development and client meetings through to bid defenses and contract negotiations.</p>\n<p data-is-only-node=\"\" data-is-last-node=\"\" data-end=\"987\" data-start=\"772\">The ideal candidate is commercially driven, proactive, and energized by building lasting partnerships, navigating complex opportunities, and contributing to the success of an innovative, client-focused organization.</p>\n</div>\n</div>\n<div>&nbsp;</div>\n<div><strong>Positions Available</strong>: 1; Primarily focused on East Coast coverage in North America (Canada/US).&nbsp;</div>\n<div>&nbsp;</div>","descriptionBodyPlain":"","hostedUrl":"https://jobs.lever.co/alimentiv-2/8ecac106-9702-4d81-977a-be2fc011199f","applyUrl":"https://jobs.lever.co/alimentiv-2/8ecac106-9702-4d81-977a-be2fc011199f/apply"},{"additionalPlain":"Stay Alert to Recruitment Scams\nWe have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.\n","additional":"<div><span data-teams=\"true\"><strong>Stay Alert to Recruitment Scams</strong><br>We have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.</span></div>","categories":{"commitment":"Full-time, Permanent","department":"Clinical Services","location":"Montreal, Quebec","team":"Clinical Study Delivery - Monitoring & Site Management","allLocations":["Montreal, Quebec","Quebec City, Quebec","Toronto, Ontario","Ottawa, Ontario","Kingston, Ontario","Halifax, Nova Scotia","Vancouver, British Columbia","Calgary, Alberta"]},"createdAt":1774897959658,"descriptionPlain":"Positions available: 1 (remote based, Canada)\nMust be fluent in English and French\n \nManage, deliver and/or perform full clinical site monitoring services for one or more projects, which may include multiple services, be complex in nature and/or run on a multinational scale.  In-house based position, responsible for the design and oversight of project monitoring services including training, site/patient recruitment, site data/document management, monitoring project site budgets and regulatory filings that aligns with SOPs, study guidelines and GCP best practices.  In the function of Lead CRA, will act as primary liaison between CRAs and project team and may be required to participate in the development of project plans, protocols, CRFs, communications or other monitoring forms, documents and tools. Represents the corporation by maintaining collaborative relationships with stakeholders.\n \n \n","description":"<div>\n<div><strong>Positions available: 1 (remote based, Canada</strong><strong>)</strong></div>\n<div><span style=\"text-decoration: underline;\"><strong>Must be fluent in English and French</strong></span></div>\n</div>\n<div>&nbsp;</div>\n<div><span style=\"font-size: 15px;\">Manage, deliver and/or perform full clinical site monitoring services for one or more projects, which may include multiple services, be complex in nature and/or run on a multinational scale.&nbsp; In-house based position, responsible for the design and oversight of project monitoring services including training, site/patient recruitment, site data/document management, monitoring project site budgets and regulatory filings that aligns with SOPs, study guidelines and GCP best practices.&nbsp; In the function of Lead CRA, will act as primary liaison between CRAs and project team and may be required to participate in the development of project plans, protocols, CRFs, communications or other monitoring forms, documents and tools. Represents the corporation by maintaining collaborative relationships with stakeholders.</span></div>\n<div>&nbsp;</div>\n<div>&nbsp;</div>","id":"38e9d31e-6c63-47d6-a0ea-056996546f67","lists":[{"text":"Monitoring - Subject Expert ","content":"\n<li>Act as subject matter expert, mentor, coach and/or provide performance feedback to manager for peers.</li>\n<li>Assist with selection, hiring, training, and supervision of CRAs as needed. Perform co-monitoring and training visits with CRAs.&nbsp;</li>\n<li>When required, act as the first escalation point for the resolution of site/patient issues or to address Sponsor concerns.</li>\n<li>May represent Director, Monitoring and Site Management or Manager, Clinical Site Management in BD initiatives with a site monitoring focus.</li>\n"},{"text":"Project Monitoring Lead","content":"\n<li>May be assigned Lead CRA role and manage monitoring services for a group of projects and/or CRAs on large/complex project(s) including directing/guiding day to day activities and review/approval of monitoring reports.</li>\n<li>Function as liaison between CRAs and other functional teams, escalating concerns and issues to management as needed.</li>\n<li>Participate and/or present at study team, kickoff and investigator meetings and act as primary contact to sponsors for all monitoring related issues.</li>\n"},{"text":"Site Recruitment and Setup ","content":"\n<li>Identify and recruit site investigators, coordinate the movement and delivery of trial materials, samples, tests and forms, including investigational product, protocols, SOPs, CRFs, project documents, forms and support tools.</li>\n<li>Ensure SOPs in place to optimize patient recruitment providing guidance to site teams of inclusion/exclusion criteria.</li>\n"},{"text":"Investigational Site Monitoring ","content":"\n<li>Primary clinical site contact.</li>\n<li>May act as primary contact for any questions or issues that arise from investigational sites.</li>\n<li>Oversee overall integrity of the study to promote positive working relationships with the site and staff.</li>\n<li>Facilitate and support site staff with access to study systems and ensure sites are compliant with project specific training requirements.</li>\n<li>Ensure all site related issues are followed until resolution.</li>\n<li>Coordinate delivery of clinical sites communications, collaborating with project teams, to ensure investigational sites are provided accurate ongoing data, updates, information and feedback on project/regulatory guidelines and objectives throughout the project lifecycle.</li>\n"},{"text":"Qualifications ","content":"\n<li>The successful candidate will possess a minimum of a college diploma/degree and 4-6 years of related experience.</li>\n<li>Self-motivation with strong communication skills and a commitment to achieving positive results.&nbsp;</li>\n<li>Strong attention to detail and keenness to understand the importance of building collaborative relationships to achieve results.&nbsp;</li>\n<li>Critical thinking abilities</li>\n<li>Ability to regularly travel to sites.</li>\n"},{"text":"Working Conditions ","content":"\n<li>Home-based</li>\n<li>Regular travel is required</li>\n"}],"salaryRange":{"currency":"CAD","interval":"per-year-salary","max":130000,"min":78000},"salaryDescription":"<div>+bonus</div>","salaryDescriptionPlain":"+bonus\n","text":"Bilingual Sr. Clinical Research Associate","country":"CA","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>\n<div><strong>Positions available: 1 (remote based, Canada</strong><strong>)</strong></div>\n<div><span style=\"text-decoration: underline;\"><strong>Must be fluent in English and French</strong></span></div>\n</div>\n<div>&nbsp;</div>\n<div><span style=\"font-size: 15px;\">Manage, deliver and/or perform full clinical site monitoring services for one or more projects, which may include multiple services, be complex in nature and/or run on a multinational scale.&nbsp; In-house based position, responsible for the design and oversight of project monitoring services including training, site/patient recruitment, site data/document management, monitoring project site budgets and regulatory filings that aligns with SOPs, study guidelines and GCP best practices.&nbsp; In the function of Lead CRA, will act as primary liaison between CRAs and project team and may be required to participate in the development of project plans, protocols, CRFs, communications or other monitoring forms, documents and tools. Represents the corporation by maintaining collaborative relationships with stakeholders.</span></div>\n<div>&nbsp;</div>\n<div>&nbsp;</div>","descriptionBodyPlain":"Positions available: 1 (remote based, Canada)\nMust be fluent in English and French\n \nManage, deliver and/or perform full clinical site monitoring services for one or more projects, which may include multiple services, be complex in nature and/or run on a multinational scale.  In-house based position, responsible for the design and oversight of project monitoring services including training, site/patient recruitment, site data/document management, monitoring project site budgets and regulatory filings that aligns with SOPs, study guidelines and GCP best practices.  In the function of Lead CRA, will act as primary liaison between CRAs and project team and may be required to participate in the development of project plans, protocols, CRFs, communications or other monitoring forms, documents and tools. Represents the corporation by maintaining collaborative relationships with stakeholders.\n \n \n","hostedUrl":"https://jobs.lever.co/alimentiv-2/38e9d31e-6c63-47d6-a0ea-056996546f67","applyUrl":"https://jobs.lever.co/alimentiv-2/38e9d31e-6c63-47d6-a0ea-056996546f67/apply"},{"additionalPlain":"PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.\n","additional":"<div><span style=\"font-size: 10pt;\">PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@</span><a rel=\"noopener noreferrer\" href=\"http://alimentiv.com/\" style=\"font-size: 10pt;\" class=\"postings-link\">alimentiv.com</a><span style=\"font-size: 10pt;\">”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.</span></div>","categories":{"commitment":"Full-time, Permanent","department":"Corporate Operations","location":"Boston, Massachusetts","team":"Business Development","allLocations":["Boston, Massachusetts","Raleigh-Durham, North Carolina","Chicago, Illinois","Newark, New Jersey","Baltimore, Maryland","Buffalo, New York","Philadelphia, Pennsylvania","Toronto, Ontario","Montreal, Quebec"]},"createdAt":1779732339216,"descriptionPlain":"The Business Development Director will be joining the BD team supporting the EU/APAC region, and supports the growth of Alimentiv business, generating sales by identifying new strategic opportunities, developing sales plans, meeting with clients, responding to requests for proposals and providing partner and vendor management support. As well, the BD Director may lead bid defenses and sponsor and vendor contract negotiations.  \n","description":"<div>\n<p><strong>ABOUT ALIMENTIV</strong></p>\n<p>Alimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.</p>\n<p>We operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.</p>\n<p>If you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you.</p>\n<p><strong>ABOUT THE OPPORTUNITY</strong></p>\n<p data-start=\"0\" data-end=\"539\">The Business Development Director will join our Business Development team supporting the Eastern US/Canada region, playing an important role in expanding Alimentiv’s global impact and helping bring innovative GI therapies closer to patients. Focused on relationship development and commercial growth, this role is responsible for identifying strategic opportunities, developing sales plans, engaging with clients, responding to proposals, and supporting partner and vendor management activities across a dynamic global market.</p>\n<p data-start=\"541\" data-end=\"1001\" data-is-last-node=\"\" data-is-only-node=\"\">Working closely with sponsors and internal cross-functional teams, the BD Director will contribute directly to new business generation through client engagement, proposal development, bid defenses, and support for sponsor and vendor contract negotiations. This is an opportunity for a commercially driven professional to combine business development expertise with meaningful work that supports research, innovation, and better outcomes for patients worldwide.</p>\n<div>\n<div><strong>Positions Available</strong>: 1; Note this position is cross-listed in multiple locations.</div>\n<div><strong>Application Deadline:</strong>&nbsp; Applications will be accepted up to, and including June 1st at 5 pm EST.&nbsp;</div>\n</div>\n</div>","id":"a2056a29-ab2d-4bd0-8891-4c7dafccd9e7","lists":[{"text":"Sales Growth and New Business Development","content":"\n<li>Achieve annual sales target objective for a defined region.</li>\n<li>Build the client base in new regions.</li>\n<li>Develop and lead client presentations.</li>\n<li>Manage as appropriate the internal proposal development process and timelines.</li>\n<li>Develop draft proposals and cost estimates based on team meetings and discussions with operational groups and provide quality control of proposal documents.</li>\n<li>Support the Director and the Contracts team throughout the contract negotiation cycle as needed. May lead the negotiations for some clients.</li>\n<li>Lead Business Development marketing activities by attending trade/scientific shows and collaborating with the Marketing group and Director BD to create various collateral including brochures, web content and presentations. &nbsp;</li>\n"},{"text":"Client Management and Sales Strategy Support","content":"\n<li>Assist the group Director with strategic sales planning and implementation.</li>\n<li>Assist the Director and Corporate Operations team with geographic expansion planning.</li>\n<li>Regularly meet with Sponsors (existing and potential) to ensure there is a clear understanding of the products/services Alimentiv offers and gauge satisfaction levels.</li>\n<li>Throughout the project life cycle provide regular information/updates to clients, addressing and/or appropriately redirecting ongoing project issues while appropriately managing client expectations.</li>\n<li>Provide support to the organization by analyzing and reporting on market trends, competitor offerings (products/pricing).</li>\n<li>Add sales/client team perspectives or provide support when the organization is developing new products or services and assessing new market growth opportunities.</li>\n"},{"text":"Partner and Project Vendor Development and Support ","content":"\n<li>Support the Clinical operations teams in identifying and sourcing new vendors required for projects following all Alimentiv and industry standard requirements.</li>\n<li>Assist with the creation, review and selection of outside vendor or partner RFPs.</li>\n<li>Lead or support as required, vendor meetings and negotiations.</li>\n<li>Support the contracts team with contract detail finalization.</li>\n<li>Support the QA team with any vendor qualification requirements.</li>\n<li>Support ongoing monitoring of vendor budgets.</li>\n"},{"text":"Qualifications","content":"\n<li>Undergraduate degree (Bachelor/Honors Bachelor) and 5-8 years of related business development, sales, or related experience, in addition to substantial ongoing education, training and/or development</li>\n\n<div>OR</div>\n\n<li>College Degree/Diploma and a minimum of 8 years' business development, sales, or related experience, in addition to substantial ongoing education, training and/or development</li>\n\n<div>&nbsp;</div>\n<div><strong>Note:</strong> Clinical Research industry experience required</div>\n<div>&nbsp;</div>\n<div><strong>Preferred Qualifications and Attributes</strong></div>\n\n<li>Educational specialization in Health Sciences or Business</li>\n<li>Significant experience in account management, including building and expanding geographical territories</li>\n<li>Extensive experience in financial resource management, including budgeting, expenditure, and revenue activities</li>\n<li>Technical expertise in contract negotiation and analysis</li>\n<li>Excellent communication skills across a range of groups internally and externally</li>\n"},{"text":"Working Conditions/Compensation","content":"\n<li>Home-based</li>\n<li>Travel to regional territory prospects as needed</li>\n\n<div>&nbsp;</div>\n<div><strong>Total Rewards:</strong></div>\n\n<li>Employee Referral Program</li>\n<li>Education Reimbursement program for full-time employees</li>\n<li>Cell phone/remote working stipend (position dependent)</li>\n<li>One-time office setup allowance upon joining</li>\n<li>Optional formal mentorship program (Alimentorship); country/region annual social events in person; leadership development programs for people leaders in accordance with your seniority; social committee and several other optional initiatives designed to support you in feeling like part of the Alimentiv team!</li>\n<li><em>Note: Accommodation for applicants with disabilities available on request</em></li>\n\n<div>&nbsp;</div>"}],"salaryRange":{"min":86000,"max":143000,"currency":"USD","interval":"per-year-salary"},"text":"Business Development Director","country":"US","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>\n<p><strong>ABOUT ALIMENTIV</strong></p>\n<p>Alimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.</p>\n<p>We operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.</p>\n<p>If you want to do meaningful work, build something real, and invest back in research that changes lives &mdash; we want to meet you.</p>\n<p><strong>ABOUT THE OPPORTUNITY</strong></p>\n<p data-end=\"539\" data-start=\"0\">The Business Development Director will join our Business Development team supporting the Eastern US/Canada region, playing an important role in expanding Alimentiv&rsquo;s global impact and helping bring innovative GI therapies closer to patients. Focused on relationship development and commercial growth, this role is responsible for identifying strategic opportunities, developing sales plans, engaging with clients, responding to proposals, and supporting partner and vendor management activities across a dynamic global market.</p>\n<p data-is-only-node=\"\" data-is-last-node=\"\" data-end=\"1001\" data-start=\"541\">Working closely with sponsors and internal cross-functional teams, the BD Director will contribute directly to new business generation through client engagement, proposal development, bid defenses, and support for sponsor and vendor contract negotiations. This is an opportunity for a commercially driven professional to combine business development expertise with meaningful work that supports research, innovation, and better outcomes for patients worldwide.</p>\n<div>\n<div><strong>Positions Available</strong>: 1; Note this position is cross-listed in multiple locations.</div>\n<div><strong>Application Deadline:</strong>&nbsp; Applications will be accepted up to, and including June 1st at 5 pm EST.&nbsp;</div>\n</div>\n</div>","descriptionBodyPlain":"The Business Development Director will be joining the BD team supporting the EU/APAC region, and supports the growth of Alimentiv business, generating sales by identifying new strategic opportunities, developing sales plans, meeting with clients, responding to requests for proposals and providing partner and vendor management support. As well, the BD Director may lead bid defenses and sponsor and vendor contract negotiations.  \n","hostedUrl":"https://jobs.lever.co/alimentiv-2/a2056a29-ab2d-4bd0-8891-4c7dafccd9e7","applyUrl":"https://jobs.lever.co/alimentiv-2/a2056a29-ab2d-4bd0-8891-4c7dafccd9e7/apply"},{"additionalPlain":"Stay Alert to Recruitment Scams\nWe have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.\n","additional":"<div><span data-teams=\"true\"><strong>Stay Alert to Recruitment Scams</strong><br>We have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.</span></div>","categories":{"commitment":"Full-time, Permanent","department":"Corporate Operations","location":"Dallas, Texas","team":"Technology and Innovation","allLocations":["Dallas, Texas"]},"createdAt":1779901513570,"descriptionPlain":"The Business Systems Analyst, CRM & ERP is an individual contributor role within Alimentiv’s Technology & Innovation function, serving as the primary functional and technical owner of the systems that power our Business Development and Finance/Accounting operations. This role requires the analytical mindset to understand, challenge, and improve how the business operates, and the hands-on technical depth to translate that understanding into effective system requirements, configurations, automations, and integrations.\nThe successful candidate will serve as the primary administrator and functional expert for Acumatica (ERP) and Salesforce (CRM), leading day-to-day system operations, driving continuous improvement initiatives, and partnering with Finance and Business Development stakeholders to optimize processes and data flows. In practice, Finance will account for the majority of this role’s time — between ongoing Acumatica operations, AP/AR and project accounting workflows, integration flows between Acumatica and SAP Concur via Celigo, and a substantial backlog of Finance-driven improvement work. The ideal candidate is equally at home in a Finance requirements meeting in the morning and a system configuration session in the afternoon, moving fluently between those two modes without losing rigour in either.\n A significant focus of the role is the integration layer connecting SAP Concur and Acumatica via Celigo middleware. The BSA will own the operational health and governance of these data flows — from invoice processing through to AP/AR — and will lead improvement initiatives as the integration environment matures.\n","description":"<div>\n<p>The Business Systems Analyst, CRM &amp; ERP is an individual contributor role within Alimentiv’s Technology &amp; Innovation function, serving as the primary functional and technical owner of the systems that power our Business Development and Finance/Accounting operations. This role requires the analytical mindset to understand, challenge, and improve how the business operates, and the hands-on technical depth to translate that understanding into effective system requirements, configurations, automations, and integrations.</p>\n<p>The successful candidate will serve as the primary administrator and functional expert for Acumatica (ERP) and Salesforce (CRM), leading day-to-day system operations, driving continuous improvement initiatives, and partnering with Finance and Business Development stakeholders to optimize processes and data flows. In practice, Finance will account for the majority of this role’s time — between ongoing Acumatica operations, AP/AR and project accounting workflows, integration flows between Acumatica and SAP Concur via Celigo, and a substantial backlog of Finance-driven improvement work. The ideal candidate is equally at home in a Finance requirements meeting in the morning and a system configuration session in the afternoon, moving fluently between those two modes without losing rigour in either.</p>\nA significant focus of the role is the integration layer connecting SAP Concur and Acumatica via Celigo middleware. The BSA will own the operational health and governance of these data flows — from invoice processing through to AP/AR — and will lead improvement initiatives as the integration environment matures.</div>","id":"640a2fdf-682b-42ec-9b3f-946d30aad545","lists":[{"text":"Acumatica ERP Administration & Finance Operations (50%)","content":"<div>\n<p>•&nbsp; Serve as the primary Acumatica administrator: configuration, user access, workflows, and module settings across Finance and related functional areas.</p>\n<p>•&nbsp; Design and implement Finance solutions using Acumatica functionality — Generic Inquiries, custom reports, approval workflows, and push notifications.</p>\n<p>•&nbsp; Support and optimize core Finance workflows: accounts payable, accounts receivable, project accounting, billing, and financial reporting.</p>\n<p>•&nbsp; Partner with Finance to define requirements, document processes, and deliver Acumatica enhancements that improve data quality and operational efficiency.</p>\n<p>•&nbsp; Troubleshoot and resolve Acumatica issues; coordinate Acumatica support while building internal capability over time.</p>\n<p>•&nbsp; Maintain and improve Acumatica TEST environment discipline — validating all configurations in TEST before promoting to Production.</p>\n</div>"},{"text":"Integration Ownership — Celigo / SAP Concur / Acumatica (25%)","content":"<div>\n<p>•&nbsp; Own the integrity and operational health of the Concur–Acumatica integration layer via Celigo.</p>\n<p>•&nbsp; Monitor integration flows for errors, investigate root causes, and coordinate resolution — serving as the primary triage owner.</p>\n<p>•&nbsp; Lead integration change governance: ensure Finance and IT follow formal intake processes before initiating vendor or system changes.</p>\n<p>•&nbsp; Document integration architecture, field mappings, data flows, and change history to enable internal troubleshooting without vendor dependency.</p>\n<p>•&nbsp; Identify and lead improvement initiatives: API version migrations, automation of manual reconciliation steps, reduction of error-prone batch processes.</p>\n<p>•&nbsp; Manage SAP Concur configuration and user administration in support of AP invoice processing workflows.</p>\n</div>"},{"text":"Salesforce CRM Administration & Business Analysis (25%)","content":"<div>\n<p>•&nbsp; Serve as the Salesforce administrator: user management, profiles, permission sets, security model, and full configuration lifecycle.</p>\n<p>•&nbsp; Design, build, and deploy custom objects, fields, page layouts, flows, validation rules, and reports/dashboards in support of the BD lifecycle.</p>\n<p>•&nbsp; Configure and maintain Sales Cloud for pipeline management, opportunity tracking, forecast accuracy, proposal generation, and contract execution.</p>\n<p>•&nbsp; Lead the future-state design and delivery of a Salesforce-to-Acumatica integration — closing the loop between BD opportunity data and project accounting. This integration does not currently exist and will be a significant initiative for this role to define and execute.</p>\n<p>•&nbsp; Engage Finance and BD stakeholders to document current-state processes, capture requirements, and produce functional specifications precise enough for developers to execute without repeated clarification.</p>\n<p>•&nbsp; Build and maintain reports and dashboards via Acumatica GIs and Power BI providing Finance and BD leadership with timely, accurate insights.</p>\n<p>•&nbsp; Communicate project status, risks, and outcomes clearly to both technical teams and senior non-technical stakeholders including Finance leadership.</p>\n</div>"},{"text":"QUALIFICATIONS","content":"<div>\n<p>•&nbsp; 5+ years in a business analyst, systems analyst, or systems administrator role supporting ERP and/or CRM platforms.</p>\n<p>•&nbsp; <strong>Required — </strong>Minimum 2 years hands-on Acumatica configuration: Generic Inquiries, workflows, user management, and Finance module administration. Candidates without direct Acumatica experience will not be considered.</p>\n<p>•&nbsp; <strong>Required — </strong>Hands-on SAP Concur experience in invoice processing, AP workflows, or system administration.</p>\n•&nbsp; Hands-on Salesforce administration experience including configuration, flow automation, and reporting; demonstrated ability to build and deploy solutions independently.</div>\n<div>&nbsp;</div>\n<div>\n<p>•&nbsp; Acumatica certification or formal Acumatica training.</p>\n•&nbsp; Salesforce Administrator certification; Advanced Administrator or Platform App Builder certifications a further asset.</div>"}],"salaryRange":{"min":86000,"max":143000,"currency":"USD","interval":"per-year-salary"},"salaryDescription":"<div>\n<p><strong>Extended Health Benefits</strong>:</p>\n<ul type=\"disc\">\n<li>Health</li>\n<li>Drug</li>\n<li>Dental</li>\n<li>Vision</li>\n<li>Out of Province/Country Emergency Health</li>\n</ul>\n<p><strong>Insurance &amp; Protection</strong>:</p>\n<ul type=\"disc\">\n<li>Accidental Death &amp; Dismemberment (AD&amp;D)</li>\n<li>Life Insurance for you and your family members</li>\n<li>Short- and Long-Term Disability</li>\n</ul>\n<p><strong>Retirement Savings</strong>:</p>\n<ul type=\"disc\">\n<li>Group Retirement Savings Plan&nbsp;</li>\n</ul>\n<p><strong>Wellness &amp; Lifestyle Perks</strong>:</p>\n<ul type=\"disc\">\n<li>Education Reimbursement of up to $750 USD(or local equivalent) annually for eligible expenses</li>\n<li>Summer Hours Program</li>\n<li>Work Abroad Program – enjoy up to 4 weeks per year of remote work outside your home region</li>\n</ul>\n<p><strong>Performance &amp; Recognition</strong>:</p>\n<ul type=\"disc\">\n<li>Short-Term Incentive Program of up to 8% of salary</li>\n</ul>\n</div>","salaryDescriptionPlain":"Extended Health Benefits:\nHealth\nDrug\nDental\nVision\nOut of Province/Country Emergency Health\nInsurance & Protection:\nAccidental Death & Dismemberment (AD&D)\nLife Insurance for you and your family members\nShort- and Long-Term Disability\nRetirement Savings:\nGroup Retirement Savings Plan \nWellness & Lifestyle Perks:\nEducation Reimbursement of up to $750 USD(or local equivalent) annually for eligible expenses\nSummer Hours Program\nWork Abroad Program – enjoy up to 4 weeks per year of remote work outside your home region\nPerformance & Recognition:\nShort-Term Incentive Program of up to 8% of salary\n","text":"Business Systems Analyst (Acumatica ERP)","country":"US","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>\n<p>The Business Systems Analyst, CRM &amp; ERP is an individual contributor role within Alimentiv&rsquo;s Technology &amp; Innovation function, serving as the primary functional and technical owner of the systems that power our Business Development and Finance/Accounting operations. This role requires the analytical mindset to understand, challenge, and improve how the business operates, and the hands-on technical depth to translate that understanding into effective system requirements, configurations, automations, and integrations.</p>\n<p>The successful candidate will serve as the primary administrator and functional expert for Acumatica (ERP) and Salesforce (CRM), leading day-to-day system operations, driving continuous improvement initiatives, and partnering with Finance and Business Development stakeholders to optimize processes and data flows. In practice, Finance will account for the majority of this role&rsquo;s time &mdash; between ongoing Acumatica operations, AP/AR and project accounting workflows, integration flows between Acumatica and SAP Concur via Celigo, and a substantial backlog of Finance-driven improvement work. The ideal candidate is equally at home in a Finance requirements meeting in the morning and a system configuration session in the afternoon, moving fluently between those two modes without losing rigour in either.</p>\nA significant focus of the role is the integration layer connecting SAP Concur and Acumatica via Celigo middleware. The BSA will own the operational health and governance of these data flows &mdash; from invoice processing through to AP/AR &mdash; and will lead improvement initiatives as the integration environment matures.</div>","descriptionBodyPlain":"The Business Systems Analyst, CRM & ERP is an individual contributor role within Alimentiv’s Technology & Innovation function, serving as the primary functional and technical owner of the systems that power our Business Development and Finance/Accounting operations. This role requires the analytical mindset to understand, challenge, and improve how the business operates, and the hands-on technical depth to translate that understanding into effective system requirements, configurations, automations, and integrations.\nThe successful candidate will serve as the primary administrator and functional expert for Acumatica (ERP) and Salesforce (CRM), leading day-to-day system operations, driving continuous improvement initiatives, and partnering with Finance and Business Development stakeholders to optimize processes and data flows. In practice, Finance will account for the majority of this role’s time — between ongoing Acumatica operations, AP/AR and project accounting workflows, integration flows between Acumatica and SAP Concur via Celigo, and a substantial backlog of Finance-driven improvement work. The ideal candidate is equally at home in a Finance requirements meeting in the morning and a system configuration session in the afternoon, moving fluently between those two modes without losing rigour in either.\n A significant focus of the role is the integration layer connecting SAP Concur and Acumatica via Celigo middleware. The BSA will own the operational health and governance of these data flows — from invoice processing through to AP/AR — and will lead improvement initiatives as the integration environment matures.\n","hostedUrl":"https://jobs.lever.co/alimentiv-2/640a2fdf-682b-42ec-9b3f-946d30aad545","applyUrl":"https://jobs.lever.co/alimentiv-2/640a2fdf-682b-42ec-9b3f-946d30aad545/apply"},{"additionalPlain":"Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle. Requests can be directed to recruitment@alimentiv.com\n \nPHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.\n \n","additional":"<div><em>Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle. Requests can be directed to recruitment@alimentiv.com</em></div>\n<div>&nbsp;</div>\n<div><span style=\"font-size: 10pt;\">PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@</span><a rel=\"noopener noreferrer\" href=\"http://alimentiv.com\" style=\"font-size: 10pt;\" class=\"postings-link\">alimentiv.com</a><span style=\"font-size: 10pt;\">”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.</span></div>\n<div>&nbsp;</div>","categories":{"commitment":"Full-time, Permanent","department":"Clinical Services","location":"Frankfurt","team":"Clinical Study Delivery - Monitoring & Site Management","allLocations":["Frankfurt","Berlin","Cologne","Dusseldorf","Hamburg","Munich","Stuttgart"]},"createdAt":1734975381704,"descriptionPlain":"Responsible for the clinical operations of a project within a defined regional/global level.  Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations.  The COL acts as a primary liaison between the CRAs and the clinical project team.  Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.  The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.\n","description":"<div>Responsible for the clinical operations of a project within a defined regional/global level.&nbsp; Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations.&nbsp; The COL acts as a primary liaison between the CRAs and the clinical project team.&nbsp; Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.&nbsp; The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.</div>","id":"1322f543-092f-4e3e-84b8-a493aaf5f1ba","lists":[{"text":"Project Oversight","content":"\n<li>Overall oversight of (a group of) regional CRAs to ensure (site) compliance with study protocol, study plans, ICH-GCP, local regulations and study timelines.</li>\n<li>Monitoring support visits (Co-monitoring), per project requirements, to aid the site/CRA in the satisfactory performance and compliance with standards mentioned above.</li>\n<li>May support clinical project team by providing oversight of study deliverables related to other departments (e.g. Data Management, TMF Operations, etc.)</li>\n<li>Oversee regional startup and feasibility activities.</li>\n<li>Assist in vendor management activities as required per project.</li>\n<li>Perform review of visit reports for quality, compliance and appropriate site management.</li>\n<li>Assure compliance with high quality and timely project deliverables according to the project requirements and the monitoring plan.</li>\n<li>Proactive management of site and country performance (recruitment, data collection, document collection, TMF review etc.) and inform clinical project team on progress.</li>\n<li>Contribute to financial project management processes as applicable.&nbsp; May include but may not be limited to input on revenue recognition, site payments, and site pass-through expense review.</li>\n<li>May be required to manage/oversee investigator sites including CRA responsibilities, on a temporary or permanent basis.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;</li>\n"},{"text":"Project Liaison","content":"\n<li>Conduct regular global CRA calls with the monitoring and site management team, as well as individual/country CRA calls&nbsp;</li>\n<li>Attend meetings with Study Sponsor to provide status updates on country and site progress</li>\n<li>Provide operational support and guidance to the monitoring team throughout project.</li>\n<li>Provide project training/mentoring to regional CRAs on study procedures, clinical plans and guidelines, and timelines for the study. Ensures study specific training requirements are completed and documented.</li>\n<li>First point of contact for regional CRAs for study-specific questions and issues. Escalates to PM and other functions as appropriate.</li>\n<li>Support line managers by providing status updates on utilization and performance of CRAs.&nbsp;</li>\n<li>Liaise with line manager for assigning sites to CRAs following line manager allocation of a CRA resource to the project.&nbsp;</li>\n<li>Conduct CRA Assessment visits per departmental requirements to assess the performance of the CRA against their monitoring responsibilities.</li>\n"},{"text":"Study Documents and Plans","content":"\n<li>Develop training materials and study tools for sites and CRAs, including monitoring plans.</li>\n<li>Develop and implement enrolment and recruitment strategies together with clinical project team.</li>\n<li>Develop presentation materials for and presents at Sponsor Kickoff meetings, Investigator meetings and Sponsor Calls (as needed), and prepares presentations for Site Qualification Visits and Site Initiation Visits.</li>\n\n<div>&nbsp;</div>"},{"text":"Qualifications ","content":"\n<li>College diploma/degree AND 7-9 years related experience +continuous training and knowledge/skills upgrading</li>\n\n<div>OR</div>\n\n<li>Undergraduate university degree (Bachelors or Honors Bachelors) AND 4-6 years' experience + substantial on-going job-related training</li>\n"},{"text":"Other","content":"\n<li>Health Sciences, Life Sciences or Nursing specialty preferred, or SoCRA and/or ACRP Certification/Designation.</li>\n<li>Should have a minimum of 3 years CRA experience, have strong experience with EDC systems, be proficient with MS Office, have strong written and verbal communication skills and highly effective interpersonal and organizational skills.</li>\n<li>Demonstrate the following attributes: proactive, detail oriented, task-driven and highly organized.</li>\n<li>Demonstrate the critical elements of GCPs and local regulations as they relate to clinical monitoring, IRB/EC and Investigator responsibilities.</li>\n<li>Demonstrated ability in report writing and strong ability to critically understand clinical research documents.</li>\n<li>Ability to handle multiple tasks to meet deadlines in a dynamic environment.&nbsp;</li>\n\n<div>&nbsp;</div>"},{"text":"Working Conditions","content":"\n<li>Home-based</li>\n"}],"salaryRange":{"min":58000,"max":96500,"currency":"EUR","interval":"per-year-salary"},"salaryDescription":"<div>+ Bonus</div>","salaryDescriptionPlain":"+ Bonus\n","text":"Clinical Operations Lead","country":"DE","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>Responsible for the clinical operations of a project within a defined regional/global level.&nbsp; Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations.&nbsp; The COL acts as a primary liaison between the CRAs and the clinical project team.&nbsp; Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.&nbsp; The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.</div>","descriptionBodyPlain":"Responsible for the clinical operations of a project within a defined regional/global level.  Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations.  The COL acts as a primary liaison between the CRAs and the clinical project team.  Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.  The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.\n","hostedUrl":"https://jobs.lever.co/alimentiv-2/1322f543-092f-4e3e-84b8-a493aaf5f1ba","applyUrl":"https://jobs.lever.co/alimentiv-2/1322f543-092f-4e3e-84b8-a493aaf5f1ba/apply"},{"additionalPlain":"Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle. Requests can be directed to recruitment@alimentiv.com\n\nPHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.\n\n","additional":"<div><i>Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle. Requests can be directed to recruitment@alimentiv.com</i></div><div><br></div><div><span style=\"font-size: 10pt;\">PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@</span><a rel=\"noopener noreferrer\" class=\"postings-link\" style=\"font-size: 10pt;\" href=\"http://alimentiv.com\">alimentiv.com</a><span style=\"font-size: 10pt;\">”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.</span></div><div><br></div>","categories":{"commitment":"Full-time, Permanent","department":"Clinical Services","location":"Warsaw","team":"Clinical Study Delivery - Monitoring & Site Management","allLocations":["Warsaw","Gdansk","Krakow","Poznan","Wroclaw"]},"createdAt":1734975178211,"descriptionPlain":"Responsible for the clinical operations of a project  within a defined regional/global level.  Provides oversight of project deliverables, assigned Clinical Research  Associate (CRAs) and Investigator sites in accordance with the Monitoring  Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local  regulations.  The COL acts as a primary liaison between the CRAs and the  clinical project team.  Additional  responsibilities include project specific training of CRAs, conducting  assessment visits with CRAs, implementation of enrollment and recruitment  strategies, preparation of the monitoring plan and other structural  documentation and the oversight of monitoring visit scheduling, site and  monitoring performance metrics, issue escalation and corrective actions.  The COL will develop study tools for site  and CRA use, review visit reports, review and track protocol deviations, and  support other objectives for clinical operations and the clinical project team.\n","description":"<div>Responsible for the clinical operations of a project  within a defined regional/global level.&nbsp; Provides oversight of project deliverables, assigned Clinical Research  Associate (CRAs) and Investigator sites in accordance with the Monitoring  Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local  regulations.&nbsp; The COL acts as a primary liaison between the CRAs and the  clinical project team.&nbsp; Additional  responsibilities include project specific training of CRAs, conducting  assessment visits with CRAs, implementation of enrollment and recruitment  strategies, preparation of the monitoring plan and other structural  documentation and the oversight of monitoring visit scheduling, site and  monitoring performance metrics, issue escalation and corrective actions.&nbsp; The COL will develop study tools for site  and CRA use, review visit reports, review and track protocol deviations, and  support other objectives for clinical operations and the clinical project team.</div>","id":"21296217-5838-4304-9e80-eb03a94417e0","lists":[{"text":"Project Oversight","content":"<li>Overall oversight of (a group of) regional CRAs to ensure (site) compliance with study protocol, study plans, ICH-GCP, local regulations and study timelines.</li><li>Monitoring support visits (Co-monitoring), per project requirements, to aid the site/CRA in the satisfactory performance and compliance with standards mentioned above.</li><li>May support clinical project team by providing oversight of study deliverables related to other departments (e.g. Data Management, TMF Operations, etc.)</li><li>Oversee regional startup and feasibility activities.</li><li>Assist in vendor management activities as required per project.</li><li>Perform review of visit reports for quality, compliance and appropriate site management.</li><li>Assure compliance with high quality and timely project deliverables according to the project requirements and the monitoring plan.</li><li>Proactive management of site and country performance (recruitment, data collection, document collection, TMF review etc.) and inform clinical project team on progress.</li><li>Contribute to financial project management processes as applicable.&nbsp; May include but may not be limited to input on revenue recognition, site payments, and site pass-through expense review.</li><li>May be required to manage/oversee investigator sites including CRA responsibilities, on a temporary or permanent basis.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;</li>"},{"text":"Project Liaison","content":"<li>Conduct regular global CRA calls with the monitoring and site management team, as well as individual/country CRA calls&nbsp;</li><li>Attend meetings with Study Sponsor to provide status updates on country and site progress</li><li>Provide operational support and guidance to the monitoring team throughout project.</li><li>Provide project training/mentoring to regional CRAs on study procedures, clinical plans and guidelines, and timelines for the study. Ensures study specific training requirements are completed and documented.</li><li>First point of contact for regional CRAs for study-specific questions and issues. Escalates to PM and other functions as appropriate.</li><li>Support line managers by providing status updates on utilization and performance of CRAs.&nbsp;</li><li>Liaise with line manager for assigning sites to CRAs following line manager allocation of a CRA resource to the project.&nbsp;</li><li>Conduct CRA Assessment visits per departmental requirements to assess the performance of the CRA against their monitoring responsibilities.</li>"},{"text":"Study Documents and Plans","content":"<li>Develop training materials and study tools for sites and CRAs, including monitoring plans.</li><li>Develop and implement enrolment and recruitment strategies together with clinical project team.</li><li>Develop presentation materials for and presents at Sponsor Kickoff meetings, Investigator meetings and Sponsor Calls (as needed), and prepares presentations for Site Qualification Visits and Site Initiation Visits.</li><div><br></div>"},{"text":"Qualifications ","content":"<li>College diploma/degree AND 7-9 years related experience +continuous training and knowledge/skills upgrading</li><div>OR</div><li>Undergraduate university degree (Bachelors or Honors Bachelors) AND 4-6 years' experience + substantial on-going job-related training </li>"},{"text":"Other","content":"<li>Health Sciences, Life Sciences or Nursing specialty preferred, or SoCRA and/or ACRP Certification/Designation.</li><li>Should have a minimum of 3 years CRA experience, have strong experience with EDC systems, be proficient with MS Office, have strong written and verbal communication skills and highly effective interpersonal and organizational skills. </li><li>Demonstrate the following attributes: proactive, detail oriented, task-driven and highly organized. </li><li>Demonstrate the critical elements of GCPs and local regulations as they relate to clinical monitoring, IRB/EC and Investigator responsibilities. </li><li>Demonstrated ability in report writing and strong ability to critically understand clinical research documents. </li><li>Ability to handle multiple tasks to meet deadlines in a dynamic environment.&nbsp;</li><div><br></div>"},{"text":"Working Conditions","content":"<li>Home-based</li>"}],"text":"Clinical Operations Lead","country":"PL","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>Responsible for the clinical operations of a project  within a defined regional/global level.&nbsp; Provides oversight of project deliverables, assigned Clinical Research  Associate (CRAs) and Investigator sites in accordance with the Monitoring  Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local  regulations.&nbsp; The COL acts as a primary liaison between the CRAs and the  clinical project team.&nbsp; Additional  responsibilities include project specific training of CRAs, conducting  assessment visits with CRAs, implementation of enrollment and recruitment  strategies, preparation of the monitoring plan and other structural  documentation and the oversight of monitoring visit scheduling, site and  monitoring performance metrics, issue escalation and corrective actions.&nbsp; The COL will develop study tools for site  and CRA use, review visit reports, review and track protocol deviations, and  support other objectives for clinical operations and the clinical project team.</div>","descriptionBodyPlain":"Responsible for the clinical operations of a project  within a defined regional/global level.  Provides oversight of project deliverables, assigned Clinical Research  Associate (CRAs) and Investigator sites in accordance with the Monitoring  Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local  regulations.  The COL acts as a primary liaison between the CRAs and the  clinical project team.  Additional  responsibilities include project specific training of CRAs, conducting  assessment visits with CRAs, implementation of enrollment and recruitment  strategies, preparation of the monitoring plan and other structural  documentation and the oversight of monitoring visit scheduling, site and  monitoring performance metrics, issue escalation and corrective actions.  The COL will develop study tools for site  and CRA use, review visit reports, review and track protocol deviations, and  support other objectives for clinical operations and the clinical project team.\n","hostedUrl":"https://jobs.lever.co/alimentiv-2/21296217-5838-4304-9e80-eb03a94417e0","applyUrl":"https://jobs.lever.co/alimentiv-2/21296217-5838-4304-9e80-eb03a94417e0/apply"},{"additionalPlain":"Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle. Requests can be directed to recruitment@alimentiv.com\n \nPHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.\n \n","additional":"<div><em>Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle. Requests can be directed to recruitment@alimentiv.com</em></div>\n<div>&nbsp;</div>\n<div><span style=\"font-size: 10pt;\">PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@</span><a rel=\"noopener noreferrer\" href=\"http://alimentiv.com\" style=\"font-size: 10pt;\" class=\"postings-link\">alimentiv.com</a><span style=\"font-size: 10pt;\">”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.</span></div>\n<div>&nbsp;</div>","categories":{"commitment":"Full-time, Permanent","department":"Clinical Services","location":"Budapest","team":"Clinical Study Delivery - Monitoring & Site Management","allLocations":["Budapest"]},"createdAt":1734975678579,"descriptionPlain":"Responsible for the clinical operations of a project within a defined regional/global level.  Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations.  The COL acts as a primary liaison between the CRAs and the clinical project team.  Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.  The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.\n","description":"<div>Responsible for the clinical operations of a project within a defined regional/global level.&nbsp; Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations.&nbsp; The COL acts as a primary liaison between the CRAs and the clinical project team.&nbsp; Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.&nbsp; The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.</div>","id":"3e3693cf-bcf6-4ca8-a28d-4272137282b5","lists":[{"text":"Project Oversight","content":"\n<li>Overall oversight of (a group of) regional CRAs to ensure (site) compliance with study protocol, study plans, ICH-GCP, local regulations and study timelines.</li>\n<li>Monitoring support visits (Co-monitoring), per project requirements, to aid the site/CRA in the satisfactory performance and compliance with standards mentioned above.</li>\n<li>May support clinical project team by providing oversight of study deliverables related to other departments (e.g. Data Management, TMF Operations, etc.)</li>\n<li>Oversee regional startup and feasibility activities.</li>\n<li>Assist in vendor management activities as required per project.</li>\n<li>Perform review of visit reports for quality, compliance and appropriate site management.</li>\n<li>Assure compliance with high quality and timely project deliverables according to the project requirements and the monitoring plan.</li>\n<li>Proactive management of site and country performance (recruitment, data collection, document collection, TMF review etc.) and inform clinical project team on progress.</li>\n<li>Contribute to financial project management processes as applicable.&nbsp; May include but may not be limited to input on revenue recognition, site payments, and site pass-through expense review.</li>\n<li>May be required to manage/oversee investigator sites including CRA responsibilities, on a temporary or permanent basis.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;</li>\n"},{"text":"Project Liaison","content":"\n<li>Conduct regular global CRA calls with the monitoring and site management team, as well as individual/country CRA calls&nbsp;</li>\n<li>Attend meetings with Study Sponsor to provide status updates on country and site progress</li>\n<li>Provide operational support and guidance to the monitoring team throughout project.</li>\n<li>Provide project training/mentoring to regional CRAs on study procedures, clinical plans and guidelines, and timelines for the study. Ensures study specific training requirements are completed and documented.</li>\n<li>First point of contact for regional CRAs for study-specific questions and issues. Escalates to PM and other functions as appropriate.</li>\n<li>Support line managers by providing status updates on utilization and performance of CRAs.&nbsp;</li>\n<li>Liaise with line manager for assigning sites to CRAs following line manager allocation of a CRA resource to the project.&nbsp;</li>\n<li>Conduct CRA Assessment visits per departmental requirements to assess the performance of the CRA against their monitoring responsibilities.</li>\n"},{"text":"Study Documents and Plans","content":"\n<li>Develop training materials and study tools for sites and CRAs, including monitoring plans.</li>\n<li>Develop and implement enrolment and recruitment strategies together with clinical project team.</li>\n<li>Develop presentation materials for and presents at Sponsor Kickoff meetings, Investigator meetings and Sponsor Calls (as needed), and prepares presentations for Site Qualification Visits and Site Initiation Visits.</li>\n\n<div>&nbsp;</div>"},{"text":"Qualifications ","content":"\n<li>College diploma/degree AND 7-9 years related experience +continuous training and knowledge/skills upgrading</li>\n\n<div>OR</div>\n\n<li>Undergraduate university degree (Bachelors or Honors Bachelors) AND 4-6 years' experience + substantial on-going job-related training</li>\n"},{"text":"Other","content":"\n<li>Health Sciences, Life Sciences or Nursing specialty preferred, or SoCRA and/or ACRP Certification/Designation.</li>\n<li>Should have a minimum of 3 years CRA experience, have strong experience with EDC systems, be proficient with MS Office, have strong written and verbal communication skills and highly effective interpersonal and organizational skills.</li>\n<li>Demonstrate the following attributes: proactive, detail oriented, task-driven and highly organized.</li>\n<li>Demonstrate the critical elements of GCPs and local regulations as they relate to clinical monitoring, IRB/EC and Investigator responsibilities.</li>\n<li>Demonstrated ability in report writing and strong ability to critically understand clinical research documents.</li>\n<li>Ability to handle multiple tasks to meet deadlines in a dynamic environment.&nbsp;</li>\n\n<div>&nbsp;</div>"},{"text":"Working Conditions","content":"\n<li>Home-based</li>\n"}],"text":"Clinical Operations Lead","country":"HU","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>Responsible for the clinical operations of a project within a defined regional/global level.&nbsp; Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations.&nbsp; The COL acts as a primary liaison between the CRAs and the clinical project team.&nbsp; Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.&nbsp; The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.</div>","descriptionBodyPlain":"Responsible for the clinical operations of a project within a defined regional/global level.  Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations.  The COL acts as a primary liaison between the CRAs and the clinical project team.  Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.  The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.\n","hostedUrl":"https://jobs.lever.co/alimentiv-2/3e3693cf-bcf6-4ca8-a28d-4272137282b5","applyUrl":"https://jobs.lever.co/alimentiv-2/3e3693cf-bcf6-4ca8-a28d-4272137282b5/apply"},{"additionalPlain":"Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle. Requests can be directed to recruitment@alimentiv.com\n \nPHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.\n \n","additional":"<div><em>Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle. Requests can be directed to recruitment@alimentiv.com</em></div>\n<div>&nbsp;</div>\n<div><span style=\"font-size: 10pt;\">PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@</span><a rel=\"noopener noreferrer\" href=\"http://alimentiv.com\" style=\"font-size: 10pt;\" class=\"postings-link\">alimentiv.com</a><span style=\"font-size: 10pt;\">”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.</span></div>\n<div>&nbsp;</div>","categories":{"commitment":"Full-time, Permanent","department":"Clinical Services","location":"Bucharest","team":"Clinical Study Delivery - Monitoring & Site Management","allLocations":["Bucharest"]},"createdAt":1734975710003,"descriptionPlain":"Responsible for the clinical operations of a project within a defined regional/global level.  Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations.  The COL acts as a primary liaison between the CRAs and the clinical project team.  Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.  The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.\n","description":"<div>Responsible for the clinical operations of a project within a defined regional/global level.&nbsp; Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations.&nbsp; The COL acts as a primary liaison between the CRAs and the clinical project team.&nbsp; Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.&nbsp; The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.</div>","id":"aefa00bd-931e-4b0d-93a9-ac37c70386fc","lists":[{"text":"Project Oversight","content":"\n<li>Overall oversight of (a group of) regional CRAs to ensure (site) compliance with study protocol, study plans, ICH-GCP, local regulations and study timelines.</li>\n<li>Monitoring support visits (Co-monitoring), per project requirements, to aid the site/CRA in the satisfactory performance and compliance with standards mentioned above.</li>\n<li>May support clinical project team by providing oversight of study deliverables related to other departments (e.g. Data Management, TMF Operations, etc.)</li>\n<li>Oversee regional startup and feasibility activities.</li>\n<li>Assist in vendor management activities as required per project.</li>\n<li>Perform review of visit reports for quality, compliance and appropriate site management.</li>\n<li>Assure compliance with high quality and timely project deliverables according to the project requirements and the monitoring plan.</li>\n<li>Proactive management of site and country performance (recruitment, data collection, document collection, TMF review etc.) and inform clinical project team on progress.</li>\n<li>Contribute to financial project management processes as applicable.&nbsp; May include but may not be limited to input on revenue recognition, site payments, and site pass-through expense review.</li>\n<li>May be required to manage/oversee investigator sites including CRA responsibilities, on a temporary or permanent basis.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;</li>\n"},{"text":"Project Liaison","content":"\n<li>Conduct regular global CRA calls with the monitoring and site management team, as well as individual/country CRA calls&nbsp;</li>\n<li>Attend meetings with Study Sponsor to provide status updates on country and site progress</li>\n<li>Provide operational support and guidance to the monitoring team throughout project.</li>\n<li>Provide project training/mentoring to regional CRAs on study procedures, clinical plans and guidelines, and timelines for the study. Ensures study specific training requirements are completed and documented.</li>\n<li>First point of contact for regional CRAs for study-specific questions and issues. Escalates to PM and other functions as appropriate.</li>\n<li>Support line managers by providing status updates on utilization and performance of CRAs.&nbsp;</li>\n<li>Liaise with line manager for assigning sites to CRAs following line manager allocation of a CRA resource to the project.&nbsp;</li>\n<li>Conduct CRA Assessment visits per departmental requirements to assess the performance of the CRA against their monitoring responsibilities.</li>\n"},{"text":"Study Documents and Plans","content":"\n<li>Develop training materials and study tools for sites and CRAs, including monitoring plans.</li>\n<li>Develop and implement enrolment and recruitment strategies together with clinical project team.</li>\n<li>Develop presentation materials for and presents at Sponsor Kickoff meetings, Investigator meetings and Sponsor Calls (as needed), and prepares presentations for Site Qualification Visits and Site Initiation Visits.</li>\n\n<div>&nbsp;</div>"},{"text":"Qualifications ","content":"\n<li>College diploma/degree AND 7-9 years related experience +continuous training and knowledge/skills upgrading</li>\n\n<div>OR</div>\n\n<li>Undergraduate university degree (Bachelors or Honors Bachelors) AND 4-6 years' experience + substantial on-going job-related training</li>\n"},{"text":"Other","content":"\n<li>Health Sciences, Life Sciences or Nursing specialty preferred, or SoCRA and/or ACRP Certification/Designation.</li>\n<li>Should have a minimum of 3 years CRA experience, have strong experience with EDC systems, be proficient with MS Office, have strong written and verbal communication skills and highly effective interpersonal and organizational skills.</li>\n<li>Demonstrate the following attributes: proactive, detail oriented, task-driven and highly organized.</li>\n<li>Demonstrate the critical elements of GCPs and local regulations as they relate to clinical monitoring, IRB/EC and Investigator responsibilities.</li>\n<li>Demonstrated ability in report writing and strong ability to critically understand clinical research documents.</li>\n<li>Ability to handle multiple tasks to meet deadlines in a dynamic environment.&nbsp;</li>\n\n<div>&nbsp;</div>"},{"text":"Working Conditions","content":"\n<li>Home-based</li>\n"}],"text":"Clinical Operations Lead","country":"RO","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>Responsible for the clinical operations of a project within a defined regional/global level.&nbsp; Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations.&nbsp; The COL acts as a primary liaison between the CRAs and the clinical project team.&nbsp; Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.&nbsp; The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.</div>","descriptionBodyPlain":"Responsible for the clinical operations of a project within a defined regional/global level.  Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations.  The COL acts as a primary liaison between the CRAs and the clinical project team.  Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.  The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.\n","hostedUrl":"https://jobs.lever.co/alimentiv-2/aefa00bd-931e-4b0d-93a9-ac37c70386fc","applyUrl":"https://jobs.lever.co/alimentiv-2/aefa00bd-931e-4b0d-93a9-ac37c70386fc/apply"},{"additional":"","additionalPlain":"","categories":{"commitment":"Full-time, Permanent","department":"Clinical Services","location":"Raleigh-Durham, North Carolina","team":"Clinical Study Delivery - Clinical Study Management - Project Management","allLocations":["Raleigh-Durham, North Carolina"]},"createdAt":1771942381699,"description":"","descriptionPlain":"","id":"2645c828-fed2-4345-b0bb-f256a4ed301c","lists":[{"text":"Project Management ","content":"\n<li>Manage the planning, execution, progress and completion of assigned clinical research projects.</li>\n<li>Work with functional experts to ensure all project activities comply with applicable regulations, guidelines, and corporate policies.</li>\n<li>Maintain operational, financial and regulatory integrity and safety.</li>\n<li>Develop and/or participate in the development of project communications, training, regulatory submissions and/or audits and selection of third party vendors as required.</li>\n\n<div>&nbsp;</div>"},{"text":"Documents and Tools","content":"\n<li>Manage a cross-functional team to ensure the appropriate creation, delivery, maintenance and disposal of all related data, documents, equipment and tools, including protocols, SOPs, informed consent forms, case report forms and instructions.</li>\n<li>Prepare investigator updates and other project related reports as required to support the proper conduct and execution throughout the life cycle of assigned projects.</li>\n"},{"text":"Project Team Performance ","content":"\n<li>Identify, assign and monitor the completion of interdisciplinary project tasks that include site monitoring, CRF and database development and revision, data collection, patient safety/adverse event management, document management, statistical analysis and/or final report writing and publications.</li>\n<li>Ensure task completion performance meets or exceeds quality standards and sponsor/client, project and regulatory expectations and guidelines.</li>\n"},{"text":"Client/Sponsor Support ","content":"\n<li>Act as primary liaison throughout the project life cycle ensuring client/sponsor expectations are appropriately managed by addressing and resolving queries/issues, planning and executing all project meetings, assisting with site and patient recruitment strategies and materials, assisting with the development of stakeholder training and by regularly providing sponsor/client with project status and update reports.</li>\n"},{"text":"Qualifications ","content":"\n<li>Applicants should have a minimum of a Bachelor's Degree in a relevant field of study (Health Sciences, Clinical Research preferred) and 1-3 years of experience in clinical study management</li>\n<li>The successful candidate must exhibit the following skills: self-motivation with strong communication skills and a commitment to achieving positive results.</li>\n<li>Strong attention to detail and keenness to understand the importance of building collaborative relationships to achieve results.</li>\n<li>Ability to engage in continuous learning and self-development.</li>\n<li>Ability to continually foster teamwork.&nbsp;</li>\n<li>Fluent in reading, writing, and speaking of English</li>\n"},{"text":"Working Conditions ","content":"\n<li>Home Based</li>\n<li>Occasional travel</li>\n\n<div>&nbsp;</div>"}],"salaryRange":{"min":95500,"max":159000,"currency":"USD","interval":"per-year-salary"},"text":"Clinical Project Manager (US)","country":"US","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"","descriptionBodyPlain":"","hostedUrl":"https://jobs.lever.co/alimentiv-2/2645c828-fed2-4345-b0bb-f256a4ed301c","applyUrl":"https://jobs.lever.co/alimentiv-2/2645c828-fed2-4345-b0bb-f256a4ed301c/apply"},{"additionalPlain":"PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.\n","additional":"<div><span style=\"font-size: 10pt;\">PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@</span><a rel=\"noopener noreferrer\" href=\"http://alimentiv.com\" style=\"font-size: 10pt;\" class=\"postings-link\">alimentiv.com</a><span style=\"font-size: 10pt;\">”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.</span></div>","categories":{"commitment":"Full-time, Permanent","department":"Clinical Services","location":"Warsaw","team":"Clinical Study Delivery - Monitoring & Site Management","allLocations":["Warsaw"]},"createdAt":1757439830989,"descriptionPlain":"Primarily a training and development role, this position will support and observe clinical site monitoring services both inhouse and in the field whilst developing CRA skills and knowledge. This role will have exposure and training in all aspects of the clinical site monitoring services whilst providing monitoring and site management activities for full-service studies assessing for protocol, SOP, and regulatory compliance. Responsibilities include site management activities to help drive investigative site and patient recruitment, compliance, and oversight. Conduct remote data review, support data query and closure activities, support Risk Based Monitoring (RBM) activities, assess data collection and (regulatory) document collection, perform remote and onsite activities for investigational sites including site contacts, qualification, initiation, monitoring and close out visits under supervision and/or independently and in accordance with corporate, sponsor and regulatory (ICH GCP and other) standards and guidelines. Represents the corporation by maintaining collaborative relationships with stakeholders.\n \nPositions available: 1 (remote within Poland)\n","description":"<div>Primarily a training and development role, this position will support and observe clinical site monitoring services both inhouse and in the field whilst developing CRA skills and knowledge. This role will have exposure and training in all aspects of the clinical site monitoring services whilst providing monitoring and site management activities for full-service studies assessing for protocol, SOP, and regulatory compliance. Responsibilities include site management activities to help drive investigative site and patient recruitment, compliance, and oversight. Conduct remote data review, support data query and closure activities, support Risk Based Monitoring (RBM) activities, assess data collection and (regulatory) document collection, perform remote and onsite activities for investigational sites including site contacts, qualification, initiation, monitoring and close out visits under supervision and/or independently and in accordance with corporate, sponsor and regulatory (ICH GCP and other) standards and guidelines. Represents the corporation by maintaining collaborative relationships with stakeholders.</div>\n<div>&nbsp;</div>\n<div>Positions available: 1 (remote within Poland)</div>","id":"6a19388e-a779-4a9b-8fcb-c37e9173a19a","lists":[{"text":"Site Management","content":"\n<li>Conducts and documents remote site contacts which could include remote site initiation, monitoring and close out visits. Documents activities per SOPs and study guidance.</li>\n<li>Conducts and documents onsite activities such as feasibility, qualification, initiation, monitoring and close out visits under supervision. Documents activities per SOPs and study guidance.</li>\n<li>Conduct remote data review of EDC, CTMS, RBM and other clinical systems to ensure alignment with SOPs, study guidelines and GCP best practices.&nbsp; Identify trends within and across study sites and escalate findings appropriately.</li>\n<li>Routinely reviews the site section of the TMF for accuracy, timeliness, and completeness. Requests new/updated documents from the site/primary assigned CRA, as required</li>\n<li>Support CRA II, Snr CRA and Lead CRA’s in day-to-day study management activities.</li>\n<li>Remotely monitor, resolve and/or facilitate resolution of queries arising out of regular and/or safety reviews, adverse events, and other data management activities throughout the trial.</li>\n<li>Coordinate delivery of clinical sites communications, collaborating with project teams, to ensure investigational sites are provided accurate ongoing data, updates, information and feedback on project/regulatory guidelines and objectives throughout the project life cycle.</li>\n<li>Supports preparation for audit and required follow-up actions.&nbsp;&nbsp;</li>\n"},{"text":"Training and Development","content":"\n<li>Successfully complete CRA development track activities and milestones.</li>\n<li>Develop and demonstrate competencies required to fulfill the role of a CRA.</li>\n<li>Support and observe primary assigned CRAs at both onsite and remote visits.</li>\n<li>Support Lead CRA’s with remote site management activities.</li>\n<li>Participate on all study related activities, including but not limited to trainings, team meetings and provide any necessary updates to the study team.</li>\n"},{"text":"Qualifications","content":"\n<li>The successful candidate will possess a minimum of a college diploma/degree and 1-3 years related experience.</li>\n<li>SoCRA, CCRA and/or ACRP certification/designation is an asset.</li>\n<li>The successful candidate must exhibit the following skills: self-motivation with strong communication skills and a commitment to achieving positive results.&nbsp;</li>\n<li>Strong attention to detail and keenness to understand the importance of building collaborative relationships to achieve results.&nbsp;</li>\n<li>Ability to engage in continuous learning and self-development.&nbsp;</li>\n<li>Ability to continually foster teamwork.</li>\n"},{"text":"Working Conditions ","content":"\n<li>Home-based</li>\n<li>Regular travel</li>\n"}],"text":"Clinical Research Associate II (Poland)","country":"PL","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>Primarily a training and development role, this position will support and observe clinical site monitoring services both inhouse and in the field whilst developing CRA skills and knowledge. This role will have exposure and training in all aspects of the clinical site monitoring services whilst providing monitoring and site management activities for full-service studies assessing for protocol, SOP, and regulatory compliance. Responsibilities include site management activities to help drive investigative site and patient recruitment, compliance, and oversight. Conduct remote data review, support data query and closure activities, support Risk Based Monitoring (RBM) activities, assess data collection and (regulatory) document collection, perform remote and onsite activities for investigational sites including site contacts, qualification, initiation, monitoring and close out visits under supervision and/or independently and in accordance with corporate, sponsor and regulatory (ICH GCP and other) standards and guidelines. Represents the corporation by maintaining collaborative relationships with stakeholders.</div>\n<div>&nbsp;</div>\n<div>Positions available: 1 (remote within Poland)</div>","descriptionBodyPlain":"Primarily a training and development role, this position will support and observe clinical site monitoring services both inhouse and in the field whilst developing CRA skills and knowledge. This role will have exposure and training in all aspects of the clinical site monitoring services whilst providing monitoring and site management activities for full-service studies assessing for protocol, SOP, and regulatory compliance. Responsibilities include site management activities to help drive investigative site and patient recruitment, compliance, and oversight. Conduct remote data review, support data query and closure activities, support Risk Based Monitoring (RBM) activities, assess data collection and (regulatory) document collection, perform remote and onsite activities for investigational sites including site contacts, qualification, initiation, monitoring and close out visits under supervision and/or independently and in accordance with corporate, sponsor and regulatory (ICH GCP and other) standards and guidelines. Represents the corporation by maintaining collaborative relationships with stakeholders.\n \nPositions available: 1 (remote within Poland)\n","hostedUrl":"https://jobs.lever.co/alimentiv-2/6a19388e-a779-4a9b-8fcb-c37e9173a19a","applyUrl":"https://jobs.lever.co/alimentiv-2/6a19388e-a779-4a9b-8fcb-c37e9173a19a/apply"},{"additional":"","additionalPlain":"","categories":{"commitment":"Full-time, Permanent","department":"Clinical Services","location":"Toronto, Ontario","team":"Clinical Services - Statistics - Statistics & Programming","allLocations":["Toronto, Ontario","London, Ontario","Calgary, Alberta","Edmonton, Alberta","Halifax, Nova Scotia","Kitchener, Ontario","Montreal, Quebec","Ottawa, Ontario","Sherbrooke, Quebec","Saskatoon, Saskatchewan","St. Catherines, Ontario"]},"createdAt":1769183031399,"descriptionPlain":"As a member of Alimentiv’s Statistical Center of Excellence, the Consulting Statistician is responsible for the research, development, and application of innovative biostatistical methods to support clients in clinical study design and implementation. This role advises internal and external clients on statistical planning, study design, data analyses, reporting and interpretation in accordance with project, regulatory and Alimentiv quality standards. Maintains contemporaneous knowledge of statistical methods, industry standards, and regulatory requirements in assigned therapy areas. Provides statistical education and communicates abstract statistical concepts in a manner such that non-statistical colleagues and clients can make informed decisions. Demonstrates thought leadership though contributions to website content and scientific publications and by delivering presentations at conferences or via webinar. Contributes to business development opportunities by meeting with potential clients and contributing to study proposals and capabilities presentations· \n \nPositions available: 1 (remote based, Canada or USA)\n","description":"<div>As a member of Alimentiv’s Statistical Center of Excellence, the Consulting Statistician is responsible for the research, development, and application of innovative biostatistical methods to support clients in clinical study design and implementation. This role advises internal and external clients on statistical planning, study design, data analyses, reporting and interpretation in accordance with project, regulatory and Alimentiv quality standards. Maintains contemporaneous knowledge of statistical methods, industry standards, and regulatory requirements in assigned therapy areas. Provides statistical education and communicates abstract statistical concepts in a manner such that non-statistical colleagues and clients can make informed decisions. Demonstrates thought leadership though contributions to website content and scientific publications and by delivering presentations at conferences or via webinar. Contributes to business development opportunities by meeting with potential clients and contributing to study proposals and capabilities presentations·&nbsp;</div>\n<div>&nbsp;</div>\n<div><strong>Positions available: 1 (remote based, Canada or USA)</strong></div>","id":"7b76c07f-ed8a-4ca1-b190-5850658c2e46","lists":[{"text":"Statistical Consulting Services","content":"\n<li>Communicates with clients and internal stakeholders to understand their statistical and clinical needs. Provides recommendations, guidance, and education on statistical concepts. Creates supplementary materials such as slides or reports to assist in communication and understanding of recommendations and concepts.&nbsp; Provides critique of and recommendations for study design after investigating innovative methods, accepted industry standards, and regulatory requirements.</li>\n<li>Prepares statistical analysis plans and oversee project data collection, management, and analysis, with input from the project team, incorporating details regarding the type of information collected, sample size, randomization procedures, table and listing shells, project statistical policies, protocols, and methodology to be used to appropriately translate scientific questions into statistical hypotheses.</li>\n<li>Reviews, edits, and assists in preparing statistical sections of study synopses, protocols, reports, publications, or presentations in collaboration with clients and internal stakeholders ensuring statistical analyses adhere to trial, sponsor, organizational and regulatory requirements, and best practices.</li>\n<li>Advises and consults with various departments internally ensuring that strategies include critical project success factors.</li>\n<li>Oversees and supports project teams in relevant studies; analyzes implementation gaps and works with relevant stakeholders to close them.</li>\n"},{"text":"Professional Development and Thought Leadership","content":"\n<li>Stays up to date on new innovations in statistical methods, especially in study design relating to chosen or assigned areas of focus.</li>\n<li>Reviews statistical research papers, learning new statistical techniques and methodologies, and maintaining subject matter expertise.</li>\n<li>Reviews literature related to clinical research, assigned therapy areas and in the areas of clients’ studies to pair with statistical knowledge to provide guidance that is innovative and in line with the needs and standards.</li>\n<li>Represents Alimentiv at relevant scientific meetings and congresses and attends trainings relating to statistics, clinical research, and medical areas of interest to continue knowledge growth and expertise.</li>\n"},{"text":"Business Development Support","content":"\n<li>Working in conjunction with the Statistics and Medical Research and Development teams, develops and presents new and novel clinical trial designs and processes and statistical methodologies into publishable and promotable scientific operations and results.</li>\n<li>Creates materials such as white papers, case studies, and statistical education materials for presentation and posting on Alimentiv websites to foster client relationship development and attract new clients.</li>\n<li>Leads or supports strategy discussions and development of proposals for Statistical Center of Excellence projects.</li>\n<li>Provides the proposal lead and functional leads with information necessary to prepare an accurate proposal that meets the strategy parameters.&nbsp;</li>\n<li>Involved in frequent client meetings/presentations and responsible for transferring knowledge to applicable project team members regarding the proposal/study strategy at the time of a bid defense.</li>\n"},{"text":"Qualifications","content":"\n<li>Candidates should posses a Master's degree and a minimum of 4-6 years of related experience. Advanced degrees in Statistics/Biostats is considered an asset.</li>\n<li>The ability to communicate abstract concepts</li>\n<li>Highly refined oral and written communication skills</li>\n<li>High level of presentation skills</li>\n"},{"text":"Warning","content":"\n<li>PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.</li>\n"}],"salaryRange":{"min":99500,"max":166000,"currency":"CAD","interval":"per-year-salary"},"salaryDescription":"<div><span data-teams=\"true\"><strong>Stay Alert to Recruitment Scams</strong><br>We have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.</span></div>","salaryDescriptionPlain":"Stay Alert to Recruitment Scams\nWe have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.\n","text":"Consulting Statistician","country":"CA","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>As a member of Alimentiv&rsquo;s Statistical Center of Excellence, the Consulting Statistician is responsible for the research, development, and application of innovative biostatistical methods to support clients in clinical study design and implementation. This role advises internal and external clients on statistical planning, study design, data analyses, reporting and interpretation in accordance with project, regulatory and Alimentiv quality standards. Maintains contemporaneous knowledge of statistical methods, industry standards, and regulatory requirements in assigned therapy areas. Provides statistical education and communicates abstract statistical concepts in a manner such that non-statistical colleagues and clients can make informed decisions. Demonstrates thought leadership though contributions to website content and scientific publications and by delivering presentations at conferences or via webinar. Contributes to business development opportunities by meeting with potential clients and contributing to study proposals and capabilities presentations&middot;&nbsp;</div>\n<div>&nbsp;</div>\n<div><strong>Positions available: 1 (remote based, Canada or USA)</strong></div>","descriptionBodyPlain":"As a member of Alimentiv’s Statistical Center of Excellence, the Consulting Statistician is responsible for the research, development, and application of innovative biostatistical methods to support clients in clinical study design and implementation. This role advises internal and external clients on statistical planning, study design, data analyses, reporting and interpretation in accordance with project, regulatory and Alimentiv quality standards. Maintains contemporaneous knowledge of statistical methods, industry standards, and regulatory requirements in assigned therapy areas. Provides statistical education and communicates abstract statistical concepts in a manner such that non-statistical colleagues and clients can make informed decisions. Demonstrates thought leadership though contributions to website content and scientific publications and by delivering presentations at conferences or via webinar. Contributes to business development opportunities by meeting with potential clients and contributing to study proposals and capabilities presentations· \n \nPositions available: 1 (remote based, Canada or USA)\n","hostedUrl":"https://jobs.lever.co/alimentiv-2/7b76c07f-ed8a-4ca1-b190-5850658c2e46","applyUrl":"https://jobs.lever.co/alimentiv-2/7b76c07f-ed8a-4ca1-b190-5850658c2e46/apply"},{"additionalPlain":"Stay Alert to Recruitment Scams\nWe have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.\n","additional":"<div><span data-teams=\"true\"><strong>Stay Alert to Recruitment Scams</strong><br>We have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.</span></div>","categories":{"commitment":"Full-time, Permanent","department":"Clinical Services","location":"Atlanta, Georgia","team":"Clinical Services - Statistics - Statistics & Programming","allLocations":["Atlanta, Georgia","San Diego, California","Raleigh-Durham, North Carolina","Boston, Massachusetts","Austin, Texas","Baltimore, Maryland","Chicago, Illinois","Dallas, Texas","Columbus, Ohio","Denver, Colorado","Houston, Texas","Los Angeles, California","Minneapolis, Minnesota","New York, New York","Philadelphia, Pennsylvania"]},"createdAt":1769183243957,"descriptionPlain":"As a member of Alimentiv’s Statistical Center of Excellence, the Consulting Statistician is responsible for the research, development, and application of innovative biostatistical methods to support clients in clinical study design and implementation. This role advises internal and external clients on statistical planning, study design, data analyses, reporting and interpretation in accordance with project, regulatory and Alimentiv quality standards. Maintains contemporaneous knowledge of statistical methods, industry standards, and regulatory requirements in assigned therapy areas. Provides statistical education and communicates abstract statistical concepts in a manner such that non-statistical colleagues and clients can make informed decisions. Demonstrates thought leadership though contributions to website content and scientific publications and by delivering presentations at conferences or via webinar. Contributes to business development opportunities by meeting with potential clients and contributing to study proposals and capabilities presentations·\n \nPositions available: 1 (remote based, Canada or USA)\n","description":"<div>As a member of Alimentiv’s Statistical Center of Excellence, the Consulting Statistician is responsible for the research, development, and application of innovative biostatistical methods to support clients in clinical study design and implementation. This role advises internal and external clients on statistical planning, study design, data analyses, reporting and interpretation in accordance with project, regulatory and Alimentiv quality standards. Maintains contemporaneous knowledge of statistical methods, industry standards, and regulatory requirements in assigned therapy areas. Provides statistical education and communicates abstract statistical concepts in a manner such that non-statistical colleagues and clients can make informed decisions. Demonstrates thought leadership though contributions to website content and scientific publications and by delivering presentations at conferences or via webinar. Contributes to business development opportunities by meeting with potential clients and contributing to study proposals and capabilities presentations·</div>\n<div>&nbsp;</div>\n<div><strong>Positions available: 1 (remote based, Canada or USA)</strong></div>","id":"928e145b-2f5b-4b4b-86ac-7e6eb0373095","lists":[{"text":"Statistical Consulting Services","content":"\n<li>Communicates with clients and internal stakeholders to understand their statistical and clinical needs. Provides recommendations, guidance, and education on statistical concepts. Creates supplementary materials such as slides or reports to assist in communication and understanding of recommendations and concepts.&nbsp; Provides critique of and recommendations for study design after investigating innovative methods, accepted industry standards, and regulatory requirements.</li>\n<li>Prepares statistical analysis plans and oversee project data collection, management, and analysis, with input from the project team, incorporating details regarding the type of information collected, sample size, randomization procedures, table and listing shells, project statistical policies, protocols, and methodology to be used to appropriately translate scientific questions into statistical hypotheses.</li>\n<li>Reviews, edits, and assists in preparing statistical sections of study synopses, protocols, reports, publications, or presentations in collaboration with clients and internal stakeholders ensuring statistical analyses adhere to trial, sponsor, organizational and regulatory requirements, and best practices.</li>\n<li>Advises and consults with various departments internally ensuring that strategies include critical project success factors.</li>\n<li>Oversees and supports project teams in relevant studies; analyzes implementation gaps and works with relevant stakeholders to close them.</li>\n"},{"text":"Professional Development and Thought Leadership","content":"\n<li>Stays up to date on new innovations in statistical methods, especially in study design relating to chosen or assigned areas of focus.</li>\n<li>Reviews statistical research papers, learning new statistical techniques and methodologies, and maintaining subject matter expertise.</li>\n<li>Reviews literature related to clinical research, assigned therapy areas and in the areas of clients’ studies to pair with statistical knowledge to provide guidance that is innovative and in line with the needs and standards.</li>\n<li>Represents Alimentiv at relevant scientific meetings and congresses and attends trainings relating to statistics, clinical research, and medical areas of interest to continue knowledge growth and expertise.</li>\n"},{"text":"Business Development Support","content":"\n<li>Working in conjunction with the Statistics and Medical Research and Development teams, develops and presents new and novel clinical trial designs and processes and statistical methodologies into publishable and promotable scientific operations and results.</li>\n<li>Creates materials such as white papers, case studies, and statistical education materials for presentation and posting on Alimentiv websites to foster client relationship development and attract new clients.</li>\n<li>Leads or supports strategy discussions and development of proposals for Statistical Center of Excellence projects.</li>\n<li>Provides the proposal lead and functional leads with information necessary to prepare an accurate proposal that meets the strategy parameters.&nbsp;</li>\n<li>Involved in frequent client meetings/presentations and responsible for transferring knowledge to applicable project team members regarding the proposal/study strategy at the time of a bid defense.</li>\n"},{"text":"Qualifications","content":"\n<li>Candidates should posses a Master's degree and a minimum of 4-6 years of related experience. Advanced degrees in Statistics/Biostats is considered an asset.</li>\n<li>The ability to communicate abstract concepts</li>\n<li>Highly refined oral and written communication skills</li>\n<li>High level of presentation skills</li>\n"}],"salaryRange":{"min":110500,"max":184000,"currency":"USD","interval":"per-year-salary"},"text":"Consulting Statistician","country":"US","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>As a member of Alimentiv&rsquo;s Statistical Center of Excellence, the Consulting Statistician is responsible for the research, development, and application of innovative biostatistical methods to support clients in clinical study design and implementation. This role advises internal and external clients on statistical planning, study design, data analyses, reporting and interpretation in accordance with project, regulatory and Alimentiv quality standards. Maintains contemporaneous knowledge of statistical methods, industry standards, and regulatory requirements in assigned therapy areas. Provides statistical education and communicates abstract statistical concepts in a manner such that non-statistical colleagues and clients can make informed decisions. Demonstrates thought leadership though contributions to website content and scientific publications and by delivering presentations at conferences or via webinar. Contributes to business development opportunities by meeting with potential clients and contributing to study proposals and capabilities presentations&middot;</div>\n<div>&nbsp;</div>\n<div><strong>Positions available: 1 (remote based, Canada or USA)</strong></div>","descriptionBodyPlain":"As a member of Alimentiv’s Statistical Center of Excellence, the Consulting Statistician is responsible for the research, development, and application of innovative biostatistical methods to support clients in clinical study design and implementation. This role advises internal and external clients on statistical planning, study design, data analyses, reporting and interpretation in accordance with project, regulatory and Alimentiv quality standards. Maintains contemporaneous knowledge of statistical methods, industry standards, and regulatory requirements in assigned therapy areas. Provides statistical education and communicates abstract statistical concepts in a manner such that non-statistical colleagues and clients can make informed decisions. Demonstrates thought leadership though contributions to website content and scientific publications and by delivering presentations at conferences or via webinar. Contributes to business development opportunities by meeting with potential clients and contributing to study proposals and capabilities presentations·\n \nPositions available: 1 (remote based, Canada or USA)\n","hostedUrl":"https://jobs.lever.co/alimentiv-2/928e145b-2f5b-4b4b-86ac-7e6eb0373095","applyUrl":"https://jobs.lever.co/alimentiv-2/928e145b-2f5b-4b4b-86ac-7e6eb0373095/apply"},{"additionalPlain":"What you can expect:\nExtended health benefits:\nHealth,\nDrug,\nDental, \nVision, \nOut of Province/Country Emergency Health\nAccidental Death and Dismemberment, Life Insurance for you and your family members, Short- and Long-Term Disability\nLife Insurance for you and your family members\nRRSP matching program \nIn addition, as an Alimentiv Employee, you’re also eligible for the following programs:\nGenerous Vacation & Time-Off Allowances, including annual company-wide time-off between Christmas & New Year's\nEducation Reimbursement program for full-time employees \nCell-phone & Remote Work Allowance on a Monthly Basis\nOffice setup allowance (can be used to purchase a scanner/printer, extra monitor, office furniture, etc.)\nFull-time employees also become beneficiaries of the Alimentiv Trust after one year of employment, and permanent members after 5 years of employment\nOptional formal mentorship program (Alimentorship); country/region annual social events in person; leadership development programs for people leaders in accordance with your seniority; social committee and several other optional initiatives designed to support you in feeling like part of the Alimentiv team!\n \n","additional":"<div>\n<blockquote>\n<div>\n<div>\n<div>\n<div>\n<blockquote>\n<p><span data-olk-copy-source=\"MessageBody\">What you can expect:</span></p>\n<p><span data-olk-copy-source=\"MessageBody\">Extended health benefits:</span></p>\n<ul>\n<li>Health,</li>\n<li>Drug,</li>\n<li>Dental,&nbsp;</li>\n<li>Vision,&nbsp;</li>\n<li>Out of Province/Country Emergency Health</li>\n<li>Accidental Death and Dismemberment, Life Insurance for you and your family members, Short- and Long-Term Disability</li>\n<li>Life Insurance for you and your family members</li>\n<li>RRSP matching program&nbsp;</li>\n</ul>\n<p>In addition, as an Alimentiv Employee, you’re also eligible for the following programs:</p>\n<ul>\n<li>Generous Vacation &amp; Time-Off Allowances, including annual company-wide time-off between Christmas &amp; New Year's</li>\n<li>Education Reimbursement program for full-time employees&nbsp;</li>\n<li>Cell-phone &amp; Remote Work Allowance on a Monthly Basis</li>\n<li>Office setup allowance (can be used to purchase a scanner/printer, extra monitor, office furniture, etc.)</li>\n<li>Full-time employees also become beneficiaries of the Alimentiv Trust after one year of employment, and permanent members after 5 years of employment</li>\n<li>Optional formal mentorship program (Alimentorship); country/region annual social events in person; leadership development programs for people leaders in accordance with your seniority; social committee and several other optional initiatives designed to support you in feeling like part of the Alimentiv team!</li>\n</ul>\n</blockquote>\n<div>&nbsp;</div>\n</div>\n</div>\n</div>\n</div>\n</blockquote>\n</div>","categories":{"commitment":"Full-time, Permanent","department":"Corporate Operations","location":"Toronto, Ontario","team":"Accounting","allLocations":["Toronto, Ontario","London, Ontario","Montreal, Quebec","Ottawa, Ontario","Halifax, Nova Scotia"]},"createdAt":1779641955604,"descriptionPlain":"ABOUT ALIMENTIV\nAlimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.\nWe operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.\nIf you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you.\nTHE OPPORTUNITY\nThe Controller exists to provide strategic and operational leadership over Alimentiv's accounting function, ensuring the integrity, accuracy, and timeliness of all financial reporting and core accounting operations. Reporting to the Chief Financial Officer, this role is responsible for overseeing the full accounting cycle including financial statement preparation, ERP systems ownership, tax and audit compliance, and end-to-end management of payables, receivables, and procurement. As the organization continues to grow across a complex multi-entity global structure, this role ensures the financial controls, processes, and systems that underpin sound business decision-making remain robust and compliant. The Controller distinguishes itself from financial planning and analysis roles by its focus on accounting operations and financial reporting rather than forecasting, budgeting, or commercial finance.\nPositions Available: 1\nApplication Deadline:  Applications will be accepted up to, and including June 1st, 2026 at 5 pm EST, and may remain open until a suitable candidate is identified. \n","description":"<div>\n<p><strong>ABOUT ALIMENTIV</strong></p>\n<p>Alimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.</p>\n<p>We operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.</p>\n<p>If you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you.</p>\n<p><strong>THE OPPORTUNITY</strong></p>\n<p>The Controller exists to provide strategic and operational leadership over Alimentiv's accounting function, ensuring the integrity, accuracy, and timeliness of all financial reporting and core accounting operations. Reporting to the Chief Financial Officer, this role is responsible for overseeing the full accounting cycle including financial statement preparation, ERP systems ownership, tax and audit compliance, and end-to-end management of payables, receivables, and procurement. As the organization continues to grow across a complex multi-entity global structure, this role ensures the financial controls, processes, and systems that underpin sound business decision-making remain robust and compliant. The Controller distinguishes itself from financial planning and analysis roles by its focus on accounting operations and financial reporting rather than forecasting, budgeting, or commercial finance.</p>\n<div><strong>Positions Available</strong>: 1</div>\n<div><strong>Application Deadline:</strong>&nbsp; Applications will be accepted up to, and including June 1st, 2026 at 5 pm EST, and may remain open until a suitable candidate is identified.&nbsp;</div>\n</div>","id":"36bc7c3f-d60b-43d1-b293-dc4a4a951729","lists":[{"text":"What you'll be responsible for:","content":"<div>&nbsp;</div>\n<div><strong>Financial Reporting and Accounting Operations (35%)&nbsp;</strong></div>\n\n<li>&nbsp;Oversee the month-end and year-end close process, including preparation and review of consolidations, journal entries, account reconciliations, and financial statements in accordance with GAAP or IFRS standards.&nbsp;</li>\n<li>Ensure the accuracy and completeness of financial reports prepared for senior leadership, the CFO, and external stakeholders.</li>\n<li>Review and sign off on financial data prepared by the accounting team, identifying and resolving discrepancies or reporting deficiencies before distribution.</li>\n<li>Lead the preparation of financial statements and supporting schedules required for audit, regulatory, and governance purposes.</li>\n<li>Monitor accounting close timelines and proactively address bottlenecks to ensure deadlines are consistently met.</li>\n<li>Maintain and enforce accounting policies and internal controls to preserve financial integrity and reduce risk across the organization.</li>\n<li>&nbsp;</li>\n\n<div><strong>ERP Systems Ownership (20%</strong>)</div>\n\n<li>Serve as the functional owner of the ERP platform, accountable for system administration, configuration, data integrity, and ongoing optimization to support accounting operations.</li>\n<li>Monitor ERP system health and workflow efficiency, identifying and resolving issues that affect data accuracy or operational continuity.</li>\n<li>Lead or support ERP-related projects including system upgrades, module implementations, and integration testing, coordinating with IT and Finance stakeholders.</li>\n<li>Develop and maintain ERP user documentation and procedures to support consistent and compliant use across the accounting team.&nbsp;</li>\n<li>Evaluate opportunities to leverage ERP functionality to reduce manual effort, improve data quality, and support organizational scale.</li>\n<li>&nbsp;</li>\n\n<div><strong>Payables, Receivables and Expense Management (20%)</strong>&nbsp;</div>\n\n<li>Provide oversight and direction over accounts payable, accounts receivable, credit and collections, and expense reporting functions, ensuring all processes operate accurately and within policy.&nbsp;</li>\n<li>Review and approve vendor payments within delegated authority thresholds, and oversee resolution of escalated payment disputes or collections issues.</li>\n<li>Monitor aging reports, cash flow indicators, and collection activity to ensure receivables are managed proactively and risks are identified early.</li>\n<li>Ensure expense reporting processes comply with corporate policies and that submissions are reviewed and approved in a timely manner.</li>\n<li>Identify and implement process improvements within AP, AR, and expense functions to increase efficiency and reduce error rates.</li>\n\n<div><strong>Tax, Audit and Transfer Pricing (15%)</strong>&nbsp;</div>\n\n<li>Ensure compliance with all applicable tax obligations across jurisdictions, coordinating with external tax advisors to manage filings, positions, and regulatory requirements.</li>\n<li>Manage the external audit process including preparation of audit-ready financial records, coordination of auditor requests, and timely resolution of audit findings.</li>\n<li>Oversee intercompany transfer pricing arrangements, ensuring documentation is current, defensible, and compliant with applicable regulations.</li>\n<li>Monitor changes in tax legislation and regulatory requirements and recommend adjustments to policies or processes as appropriate.</li>\n<li>Coordinate with Finance, Legal, and external advisors on tax matters with material financial or compliance impact.</li>\n\n<div><strong>Assets, Procurement and Team Leadership (10%)</strong>&nbsp;</div>\n\n<li>Oversee fixed asset management including tracking, valuation, depreciation, and disposal in accordance with accounting standards and organizational policy.</li>\n<li>Support procurement and purchasing processes, ensuring expenditures are approved within delegated authority limits and purchasing records are maintained accurately.</li>\n<li>Lead, develop, and manage the accounting team through clear direction, regular performance feedback, and professional development support.</li>\n<li>Assign and schedule work across the accounting function to ensure team capacity is aligned with operational priorities and close cycle demands.&nbsp;</li>\n"},{"text":"Who you are:","content":"<div>&nbsp;</div>\n<div><strong>Education &amp; Experience (Required):</strong></div>\n\n<li>Minimum 10 years of related experience in a progressively senior/leadership function in accounting.&nbsp;</li>\n<li>Bachelor's degree + CPA designation (required)</li>\n\n<div><strong>Skills:</strong></div>\n\n<li><em><strong>Strongly desired:</strong></em> Exposure to a global, complex multi-entity structure in a professional services or contract research operation organization (US, EU, LATAM, etc.)</li>\n<li>Deep expertise in GAAP and/or IFRS financial reporting and full-cycle accounting, including consolidations and multi-entity structures.</li>\n<li>Strong knowledge of tax compliance principles, transfer pricing rules, and audit management in a multi-jurisdiction environment.</li>\n<li>Demonstrated experience leading and managing accounting teams, including performance management, workload planning, and professional development.</li>\n<li>Hands-on experience administering and optimizing ERP platforms within a Finance context, including configuration, data integrity, and integration management.</li>\n<li>Proficiency in accounts payable, accounts receivable, credit and collections, and fixed asset management functions.</li>\n<li>Working knowledge of procurement and purchasing processes and the controls required to ensure compliance.</li>\n<li>Strong analytical and problem-solving skills, with the ability to identify root causes of financial discrepancies and implement effective corrective actions.</li>\n<li>High degree of accuracy and attention to detail in the preparation and review of financial data and reports.&nbsp;</li>\n\n<div>&nbsp;</div>\n<div>&nbsp;</div>\n<div>&nbsp;</div>"}],"salaryRange":{"min":160000,"max":180000,"currency":"CAD","interval":"per-year-salary"},"salaryDescription":"<div>Please note the range reflected above represents a typical hiring range for a candidate located in Canada - we approach compensation in accordance with the unique skills, experience, and qualifications an individual brings to the role, and are happy to discuss compensation further at time of interview.&nbsp;</div>","salaryDescriptionPlain":"Please note the range reflected above represents a typical hiring range for a candidate located in Canada - we approach compensation in accordance with the unique skills, experience, and qualifications an individual brings to the role, and are happy to discuss compensation further at time of interview. \n","text":"Controller","country":"CA","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>\n<p><strong>ABOUT ALIMENTIV</strong></p>\n<p>Alimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.</p>\n<p>We operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.</p>\n<p>If you want to do meaningful work, build something real, and invest back in research that changes lives &mdash; we want to meet you.</p>\n<p><strong>THE OPPORTUNITY</strong></p>\n<p>The Controller exists to provide strategic and operational leadership over Alimentiv's accounting function, ensuring the integrity, accuracy, and timeliness of all financial reporting and core accounting operations. Reporting to the Chief Financial Officer, this role is responsible for overseeing the full accounting cycle including financial statement preparation, ERP systems ownership, tax and audit compliance, and end-to-end management of payables, receivables, and procurement. As the organization continues to grow across a complex multi-entity global structure, this role ensures the financial controls, processes, and systems that underpin sound business decision-making remain robust and compliant. The Controller distinguishes itself from financial planning and analysis roles by its focus on accounting operations and financial reporting rather than forecasting, budgeting, or commercial finance.</p>\n<div><strong>Positions Available</strong>: 1</div>\n<div><strong>Application Deadline:</strong>&nbsp; Applications will be accepted up to, and including June 1st, 2026 at 5 pm EST, and may remain open until a suitable candidate is identified.&nbsp;</div>\n</div>","descriptionBodyPlain":"ABOUT ALIMENTIV\nAlimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.\nWe operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.\nIf you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you.\nTHE OPPORTUNITY\nThe Controller exists to provide strategic and operational leadership over Alimentiv's accounting function, ensuring the integrity, accuracy, and timeliness of all financial reporting and core accounting operations. Reporting to the Chief Financial Officer, this role is responsible for overseeing the full accounting cycle including financial statement preparation, ERP systems ownership, tax and audit compliance, and end-to-end management of payables, receivables, and procurement. As the organization continues to grow across a complex multi-entity global structure, this role ensures the financial controls, processes, and systems that underpin sound business decision-making remain robust and compliant. The Controller distinguishes itself from financial planning and analysis roles by its focus on accounting operations and financial reporting rather than forecasting, budgeting, or commercial finance.\nPositions Available: 1\nApplication Deadline:  Applications will be accepted up to, and including June 1st, 2026 at 5 pm EST, and may remain open until a suitable candidate is identified. \n","hostedUrl":"https://jobs.lever.co/alimentiv-2/36bc7c3f-d60b-43d1-b293-dc4a4a951729","applyUrl":"https://jobs.lever.co/alimentiv-2/36bc7c3f-d60b-43d1-b293-dc4a4a951729/apply"},{"additionalPlain":"PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report. \n","additional":"<div>PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.&nbsp;</div>","categories":{"commitment":"Full-time, Permanent","department":"Clinical Services","location":"Chicago, Illinois","team":"Clinical Study Delivery - Monitoring & Site Management","allLocations":["Chicago, Illinois","Jacksonville, Florida","Houston, Texas","Nashville, Tennessee","Newark, New Jersey","Philadelphia, Pennsylvania","San Diego, California","Seattle, Washington","Raleigh-Durham, North Carolina"]},"createdAt":1779991491220,"descriptionPlain":"ABOUT ALIMENTIV\nAlimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.\nWe operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.\nIf you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you.\nTHE OPPORTUNITY\nThis role is responsible for the day-to-day leadership and operational oversight of the Clinical Monitoring unit (Clinical Operations Leads), ensuring the successful delivery of high-quality clinical trial execution across global studies. Working in a fast-paced and highly collaborative environment, the role supports operational excellence through effective planning, resource management, process improvement, and a strong focus on quality and compliance.\nPartnering closely with sponsors, researchers, and cross-functional project teams throughout the study lifecycle, this individual serves as a trusted operational leader and subject matter expert for clinical monitoring activities. Responsibilities include supporting policy and process development, overseeing site and compliance monitoring practices, managing staff and contractor performance, and ensuring teams, including third-party providers, consistently deliver timely, high-quality service aligned with corporate standards, industry best practices, and global regulatory requirements.\nPositions Available: 1; Note this position is cross-listed in multiple location, and is currently open to residents of the United States and Canada.\nApplication Deadline:  Applications will be accepted up to, and including June 5th, 2026 at 5 pm EST.\n","description":"<div>\n<p><strong>ABOUT ALIMENTIV</strong></p>\n<p>Alimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.</p>\n<p>We operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.</p>\n<p>If you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you.</p>\n<p><strong>THE OPPORTUNITY</strong></p>\n</div>\n<div>\n<p data-start=\"0\" data-end=\"457\">This role is responsible for the day-to-day leadership and operational oversight of the Clinical Monitoring unit (Clinical Operations Leads), ensuring the successful delivery of high-quality clinical trial execution across global studies. Working in a fast-paced and highly collaborative environment, the role supports operational excellence through effective planning, resource management, process improvement, and a strong focus on quality and compliance.</p>\n<p data-start=\"459\" data-end=\"1053\" data-is-last-node=\"\" data-is-only-node=\"\">Partnering closely with sponsors, researchers, and cross-functional project teams throughout the study lifecycle, this individual serves as a trusted operational leader and subject matter expert for clinical monitoring activities. Responsibilities include supporting policy and process development, overseeing site and compliance monitoring practices, managing staff and contractor performance, and ensuring teams, including third-party providers, consistently deliver timely, high-quality service aligned with corporate standards, industry best practices, and global regulatory requirements.</p>\n<div><strong>Positions Available</strong>: 1; Note this position is cross-listed in multiple location, and is currently open to residents of the United States and Canada.</div>\n<div><strong>Application Deadline:</strong>&nbsp; Applications will be accepted up to, and including June 5th, 2026 at 5 pm EST.</div>\n</div>","id":"87889b9a-bca6-4f61-a7a9-4aae9f62cc5b","lists":[{"text":"Project Planning","content":"\n<li>Working in conjunction with clinical monitoring and project leadership team members, identify, develop, plan for, monitor, approve and/or report on project specific processes and services related to site selection, clinical monitoring, ICH-GCP compliance issue resolution, and global project harmonization including SOP and QS document maintenance, periodic site visits and collaborating with IT support to meet sponsor requirements on a timely basis.</li>\n"},{"text":"Customer Service Delivery","content":"\n<li>Represent and support the Clinical Monitoring teams with internal partners and external Sponsors to identify areas of improvement, to address sponsor/site concerns and to integrate new technologies and processes.&nbsp;</li>\n<li>Ensure regulatory compliance, industry best practices, and organizational goals and targets are met and/or exceeded.</li>\n"},{"text":"Team Management and Engagement","content":"\n<li>Manage members of the Clinical Monitoring teams, ensuring functional areas are adequately staffed with qualified personnel, providing ongoing support to staff in the areas of work allocation, resource planning, training and development, technology, process development, expense management, employee engagement and performance management (staff role development, evaluations, performance improvement and lost time management).</li>\n\n<div>&nbsp;</div>"},{"text":"Third Party Contract Management","content":"\n<li>Identify, procure, and manage Clinical Monitoring (Clinical Operations Leads) Independent Contractor services, including needs assessment, recruitment, contract negotiations, Corporate and Sponsor policy compliance, training and development, cost monitoring and performance management, ensuring corporate, industry and regulatory service level, guidelines and regulations are maintained.</li>\n"},{"text":"Product/Service Delivery Support","content":"\n<li>Provide expertise, developing tools to support project teams and business development in the areas of clinical, site and compliance monitoring and performance during the project life cycle starting from the bidding process through to reporting project findings to sponsors.</li>\n"},{"text":"Qualifications ","content":"\n<li>The successful candidate should have a College Diploma/University Degree in a relevant field (Health Sciences, Life Sciences preferred, or SoCRA and/or ACRP Certification/Designation) and a minimum of 4-6 years related experience + substantial on-going training.</li>\n<li>Experience in managing CRA staff and ability to provide training and/or mentorship to colleagues on a 1:1 basis or meeting setting.</li>\n<li>Ability to work in a remote global capacity</li>\n<li>Strong knowledge of appropriate regulations and guidelines as they pertain to clinical monitoring and GCP.</li>\n<li>Team player that has a customer service approach and is solution oriented.</li>\n<li>Demonstrated leadership skills</li>\n<li>Strong verbal, written, and organizational skills.</li>\n<li>Ability to handle multiple tasks to meet deadlines in a dynamic environment.</li>\n\n<div>&nbsp;</div>"},{"text":"Working Conditions ","content":"\n<li>Home-based</li>\n"}],"salaryRange":{"currency":"USD","interval":"per-year-salary","min":144000,"max":210000},"salaryDescription":"<div>+ bonus</div>\n<div>&nbsp;</div>\n<div>Note: While the range above is large, that is intentional, and reflects the full scale of experience we recognize that applicants may bring to the role.&nbsp;</div>","salaryDescriptionPlain":"+ bonus\n \nNote: While the range above is large, that is intentional, and reflects the full scale of experience we recognize that applicants may bring to the role. \n","text":"Director, Clinical Trial Management","country":"US","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>\n<p><strong>ABOUT ALIMENTIV</strong></p>\n<p>Alimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.</p>\n<p>We operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.</p>\n<p>If you want to do meaningful work, build something real, and invest back in research that changes lives &mdash; we want to meet you.</p>\n<p><strong>THE OPPORTUNITY</strong></p>\n</div>\n<div>\n<p data-end=\"457\" data-start=\"0\">This role is responsible for the day-to-day leadership and operational oversight of the Clinical Monitoring unit (Clinical Operations Leads), ensuring the successful delivery of high-quality clinical trial execution across global studies. Working in a fast-paced and highly collaborative environment, the role supports operational excellence through effective planning, resource management, process improvement, and a strong focus on quality and compliance.</p>\n<p data-is-only-node=\"\" data-is-last-node=\"\" data-end=\"1053\" data-start=\"459\">Partnering closely with sponsors, researchers, and cross-functional project teams throughout the study lifecycle, this individual serves as a trusted operational leader and subject matter expert for clinical monitoring activities. Responsibilities include supporting policy and process development, overseeing site and compliance monitoring practices, managing staff and contractor performance, and ensuring teams, including third-party providers, consistently deliver timely, high-quality service aligned with corporate standards, industry best practices, and global regulatory requirements.</p>\n<div><strong>Positions Available</strong>: 1; Note this position is cross-listed in multiple location, and is currently open to residents of the United States and Canada.</div>\n<div><strong>Application Deadline:</strong>&nbsp; Applications will be accepted up to, and including June 5th, 2026 at 5 pm EST.</div>\n</div>","descriptionBodyPlain":"ABOUT ALIMENTIV\nAlimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.\nWe operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.\nIf you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you.\nTHE OPPORTUNITY\nThis role is responsible for the day-to-day leadership and operational oversight of the Clinical Monitoring unit (Clinical Operations Leads), ensuring the successful delivery of high-quality clinical trial execution across global studies. Working in a fast-paced and highly collaborative environment, the role supports operational excellence through effective planning, resource management, process improvement, and a strong focus on quality and compliance.\nPartnering closely with sponsors, researchers, and cross-functional project teams throughout the study lifecycle, this individual serves as a trusted operational leader and subject matter expert for clinical monitoring activities. Responsibilities include supporting policy and process development, overseeing site and compliance monitoring practices, managing staff and contractor performance, and ensuring teams, including third-party providers, consistently deliver timely, high-quality service aligned with corporate standards, industry best practices, and global regulatory requirements.\nPositions Available: 1; Note this position is cross-listed in multiple location, and is currently open to residents of the United States and Canada.\nApplication Deadline:  Applications will be accepted up to, and including June 5th, 2026 at 5 pm EST.\n","hostedUrl":"https://jobs.lever.co/alimentiv-2/87889b9a-bca6-4f61-a7a9-4aae9f62cc5b","applyUrl":"https://jobs.lever.co/alimentiv-2/87889b9a-bca6-4f61-a7a9-4aae9f62cc5b/apply"},{"additionalPlain":"PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report. \n","additional":"<div>PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.&nbsp;</div>","categories":{"commitment":"Full-time, Permanent","department":"Clinical Services","location":"Krakow","team":"Clinical Study Delivery - Monitoring & Site Management","allLocations":["Krakow","Warsaw","Gdansk","Budapest","Bucharest","Brasilia","Rio de Janeiro","Sao Paulo","Berlin","Frankfurt","Belfast","Cambridge","London","Manchester"]},"createdAt":1780100818451,"descriptionPlain":"ABOUT ALIMENTIV\nAlimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.\nWe operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.\nIf you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you.\nTHE OPPORTUNITY\nThis role is responsible for the day-to-day leadership and operational oversight of the Clinical Monitoring unit (Clinical Operations Leads), ensuring the successful delivery of high-quality clinical trial execution across global studies. Working in a fast-paced and highly collaborative environment, the role supports operational excellence through effective planning, resource management, process improvement, and a strong focus on quality and compliance.\nPartnering closely with sponsors, researchers, and cross-functional project teams throughout the study lifecycle, this individual serves as a trusted operational leader and subject matter expert for clinical monitoring activities. Responsibilities include supporting policy and process development, overseeing site and compliance monitoring practices, managing staff and contractor performance, and ensuring teams, including third-party providers, consistently deliver timely, high-quality service aligned with corporate standards, industry best practices, and global regulatory requirements.\nPositions Available: 1; Note this position is cross-listed in multiple location, and is currently open to residents of United States, Canada, Germany, Poland, Hungary, Romania, Brazil, and the United Kingdom\nApplication Deadline:  Applications will be accepted up to, and including June 5th, 2026 at 5 pm EST.\n","description":"<div>\n<p><strong>ABOUT ALIMENTIV</strong></p>\n<p>Alimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.</p>\n<p>We operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.</p>\n<p>If you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you.</p>\n<p><strong>THE OPPORTUNITY</strong></p>\n</div>\n<div>\n<p data-start=\"0\" data-end=\"457\">This role is responsible for the day-to-day leadership and operational oversight of the Clinical Monitoring unit (Clinical Operations Leads), ensuring the successful delivery of high-quality clinical trial execution across global studies. Working in a fast-paced and highly collaborative environment, the role supports operational excellence through effective planning, resource management, process improvement, and a strong focus on quality and compliance.</p>\n<p data-start=\"459\" data-end=\"1053\" data-is-last-node=\"\" data-is-only-node=\"\">Partnering closely with sponsors, researchers, and cross-functional project teams throughout the study lifecycle, this individual serves as a trusted operational leader and subject matter expert for clinical monitoring activities. Responsibilities include supporting policy and process development, overseeing site and compliance monitoring practices, managing staff and contractor performance, and ensuring teams, including third-party providers, consistently deliver timely, high-quality service aligned with corporate standards, industry best practices, and global regulatory requirements.</p>\n<div><strong>Positions Available</strong>: 1; Note this position is cross-listed in multiple location, and is currently open to residents of United States, Canada, Germany, Poland, Hungary, Romania, Brazil, and the United Kingdom</div>\n<div><strong>Application Deadline:</strong>&nbsp; Applications will be accepted up to, and including June 5th, 2026 at 5 pm EST.</div>\n</div>","id":"979b5c05-2eee-42c5-8b72-4ce407fc10e0","lists":[{"text":"Project Planning","content":"\n<li>Working in conjunction with clinical monitoring and project leadership team members, identify, develop, plan for, monitor, approve and/or report on project specific processes and services related to site selection, clinical monitoring, ICH-GCP compliance issue resolution, and global project harmonization including SOP and QS document maintenance, periodic site visits and collaborating with IT support to meet sponsor requirements on a timely basis.</li>\n"},{"text":"Customer Service Delivery","content":"\n<li>Represent and support the Clinical Monitoring teams with internal partners and external Sponsors to identify areas of improvement, to address sponsor/site concerns and to integrate new technologies and processes.&nbsp;</li>\n<li>Ensure regulatory compliance, industry best practices, and organizational goals and targets are met and/or exceeded.</li>\n"},{"text":"Team Management and Engagement","content":"\n<li>Manage members of the Clinical Monitoring teams, ensuring functional areas are adequately staffed with qualified personnel, providing ongoing support to staff in the areas of work allocation, resource planning, training and development, technology, process development, expense management, employee engagement and performance management (staff role development, evaluations, performance improvement and lost time management).</li>\n\n<div>&nbsp;</div>"},{"text":"Third Party Contract Management","content":"\n<li>Identify, procure, and manage Clinical Monitoring (Clinical Operations Leads) Independent Contractor services, including needs assessment, recruitment, contract negotiations, Corporate and Sponsor policy compliance, training and development, cost monitoring and performance management, ensuring corporate, industry and regulatory service level, guidelines and regulations are maintained.</li>\n"},{"text":"Product/Service Delivery Support","content":"\n<li>Provide expertise, developing tools to support project teams and business development in the areas of clinical, site and compliance monitoring and performance during the project life cycle starting from the bidding process through to reporting project findings to sponsors.</li>\n"},{"text":"Qualifications ","content":"\n<li>The successful candidate should have a College Diploma/University Degree in a relevant field (Health Sciences, Life Sciences preferred, or SoCRA and/or ACRP Certification/Designation) and a minimum of 4-6 years related experience + substantial on-going training.</li>\n<li>Experience in managing CRA staff and ability to provide training and/or mentorship to colleagues on a 1:1 basis or meeting setting.</li>\n<li>Ability to work in a remote global capacity</li>\n<li>Strong knowledge of appropriate regulations and guidelines as they pertain to clinical monitoring and GCP.</li>\n<li>Team player that has a customer service approach and is solution oriented.</li>\n<li>Demonstrated leadership skills</li>\n<li>Strong verbal, written, and organizational skills.</li>\n<li>Ability to handle multiple tasks to meet deadlines in a dynamic environment.</li>\n\n<div>&nbsp;</div>"},{"text":"Working Conditions ","content":"\n<li>Home-based</li>\n"}],"salaryRange":{"currency":"EUR","interval":"per-year-salary","min":98500,"max":164000},"salaryDescription":"<div>+ bonus</div>\n<div>&nbsp;</div>\n<div>Note: While the range above is large, that is intentional, and reflects the full scale of experience we recognize that applicants may bring to the role. A member of our TA team would be happy to discuss regional compensation according to your country of residence at time of interview.&nbsp;</div>","salaryDescriptionPlain":"+ bonus\n \nNote: While the range above is large, that is intentional, and reflects the full scale of experience we recognize that applicants may bring to the role. A member of our TA team would be happy to discuss regional compensation according to your country of residence at time of interview. \n","text":"Director, Clinical Trial Management","country":"PL","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>\n<p><strong>ABOUT ALIMENTIV</strong></p>\n<p>Alimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.</p>\n<p>We operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.</p>\n<p>If you want to do meaningful work, build something real, and invest back in research that changes lives &mdash; we want to meet you.</p>\n<p><strong>THE OPPORTUNITY</strong></p>\n</div>\n<div>\n<p data-end=\"457\" data-start=\"0\">This role is responsible for the day-to-day leadership and operational oversight of the Clinical Monitoring unit (Clinical Operations Leads), ensuring the successful delivery of high-quality clinical trial execution across global studies. Working in a fast-paced and highly collaborative environment, the role supports operational excellence through effective planning, resource management, process improvement, and a strong focus on quality and compliance.</p>\n<p data-is-only-node=\"\" data-is-last-node=\"\" data-end=\"1053\" data-start=\"459\">Partnering closely with sponsors, researchers, and cross-functional project teams throughout the study lifecycle, this individual serves as a trusted operational leader and subject matter expert for clinical monitoring activities. Responsibilities include supporting policy and process development, overseeing site and compliance monitoring practices, managing staff and contractor performance, and ensuring teams, including third-party providers, consistently deliver timely, high-quality service aligned with corporate standards, industry best practices, and global regulatory requirements.</p>\n<div><strong>Positions Available</strong>: 1; Note this position is cross-listed in multiple location, and is currently open to residents of United States, Canada, Germany, Poland, Hungary, Romania, Brazil, and the United Kingdom</div>\n<div><strong>Application Deadline:</strong>&nbsp; Applications will be accepted up to, and including June 5th, 2026 at 5 pm EST.</div>\n</div>","descriptionBodyPlain":"ABOUT ALIMENTIV\nAlimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.\nWe operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.\nIf you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you.\nTHE OPPORTUNITY\nThis role is responsible for the day-to-day leadership and operational oversight of the Clinical Monitoring unit (Clinical Operations Leads), ensuring the successful delivery of high-quality clinical trial execution across global studies. Working in a fast-paced and highly collaborative environment, the role supports operational excellence through effective planning, resource management, process improvement, and a strong focus on quality and compliance.\nPartnering closely with sponsors, researchers, and cross-functional project teams throughout the study lifecycle, this individual serves as a trusted operational leader and subject matter expert for clinical monitoring activities. Responsibilities include supporting policy and process development, overseeing site and compliance monitoring practices, managing staff and contractor performance, and ensuring teams, including third-party providers, consistently deliver timely, high-quality service aligned with corporate standards, industry best practices, and global regulatory requirements.\nPositions Available: 1; Note this position is cross-listed in multiple location, and is currently open to residents of United States, Canada, Germany, Poland, Hungary, Romania, Brazil, and the United Kingdom\nApplication Deadline:  Applications will be accepted up to, and including June 5th, 2026 at 5 pm EST.\n","hostedUrl":"https://jobs.lever.co/alimentiv-2/979b5c05-2eee-42c5-8b72-4ce407fc10e0","applyUrl":"https://jobs.lever.co/alimentiv-2/979b5c05-2eee-42c5-8b72-4ce407fc10e0/apply"},{"additionalPlain":"PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report. \n","additional":"<div>PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.&nbsp;</div>","categories":{"commitment":"Full-time, Permanent","department":"Clinical Services","location":"Warsaw","team":"Clinical Study Delivery - Monitoring & Site Management","allLocations":["Warsaw"]},"createdAt":1773858665375,"descriptionPlain":"This position will support and observe clinical site monitoring services inhouse and provide monitoring and site management activities for full-service studies assessing for protocol, SOP and regulatory compliance. Responsibilities include site management activities to help drive investigative sites and patient recruitment, compliance and oversight.  Conduct remote data review, support data query and closure activities, support Risk Based Monitoring (RBM) activities, assess data collection and (regulatory) document collection, perform remote activities for investigational sites in accordance with corporate, sponsor and regulatory (ICH GCP and other) standards and guidelines. Represents the corporation by maintaining collaborative relationships with stakeholders.\n","description":"<div><span style=\"font-size: 16px;\">This position will support and observe clinical site monitoring services inhouse and provide monitoring and site management activities for full-service studies assessing for protocol, SOP and regulatory compliance. Responsibilities include site management activities to help drive investigative sites and patient recruitment, compliance and oversight.&nbsp; Conduct remote data review, support data query and closure activities, support Risk Based Monitoring (RBM) activities, assess data collection and (regulatory) document collection, perform remote activities for investigational sites in accordance with corporate, sponsor and regulatory (ICH GCP and other) standards and guidelines. Represents the corporation by maintaining collaborative relationships with stakeholders.</span></div>","id":"f6aa613e-d295-474b-b901-513de6abb6c4","lists":[{"text":"Site Management ","content":"\n<li>Serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites as required per SOPs, Monitoring Plan and study guidance, including creating contact reports for each telephone session (outbound or inbound) with sites.</li>\n<li>Act as the first point of contact for site when the CRA is absent.</li>\n<li>Manage and file site specific documents in (e) TMF.</li>\n<li>Assist Clinical Research Associates (CRA) with preparation for site visits (i.e. running reports, QC of files and checking for missing documents in the TMF, resolving action items and queries from previous visits).</li>\n<li>Perform Case Report Form review, query generation and resolution against established data review guidelines and the monitoring plan.</li>\n<li>Monitor site performance and implement action plans for sites not meeting expectations, in conjunction with the CRA.</li>\n<li>Assist with the coordination of study visits, shipment study supplies and system access or updates.</li>\n<li>Manage sites to ensure compliance with protocol requirements, study visits, and data entry timelines.</li>\n<li>Liaise with the project team and others to distribute and track clinical trial supplies, e.g. Case Report Forms, study medication, lab kits, ensuring that sites have sufficient supplies to continue recruitment.</li>\n<li>Liaise with the Project Coordinator, Project Manager and or Clinical Operation Lead (COL) in the production of Status Reports.</li>\n<li>Assist in submissions and notifications to Ethics Committees and Regulatory Authorities. As applicable in region.</li>\n<li>Occasionally, if needed, perform remote visits (i.e. qualification, site initiation, interim and close out visits) as required by the monitoring plan, but does not perform remote monitoring that requires SDV.</li>\n<li>General Monitoring Responsibilities: perform onsite visits as co-monitor if needed.</li>\n<li>Supports preparation for audit and required follow-up actions.</li>\n"},{"text":"Site Setup and Startup Support ","content":"\n<li>Potentially support with identification and recruit site investigators, coordinate the movement and delivery of trial materials, samples, tests, and forms, including investigational medicinal products, protocols, SOPs, CRFs, project documents, forms, and support tools.</li>\n<li>Support patient recruitment providing guidance to site teams of inclusion/exclusion criteria.</li>\n"},{"text":"Training and Development ","content":"\n<li>Support and observe primary assigned CRAs at both onsite and remote visits.</li>\n<li>Support COLs with remote site management activities.</li>\n<li>Participate in all study related activities, including but not limited to training, team meetings and provide any necessary updates to the study team.</li>\n"},{"text":"Qualifications","content":"\n<li>Undergraduate university degree (Bachelor or Honors Bachelor), &amp; 1-3 years' related experience with initial and On-going training.</li>\n"}],"salaryRange":{"max":14500,"min":7200,"currency":"PLN","interval":"per-month-salary"},"text":"In-House Clinical Research Associate (Poland)","country":"PL","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div><span style=\"font-size: 16px;\">This position will support and observe clinical site monitoring services inhouse and provide monitoring and site management activities for full-service studies assessing for protocol, SOP and regulatory compliance. Responsibilities include site management activities to help drive investigative sites and patient recruitment, compliance and oversight.&nbsp; Conduct remote data review, support data query and closure activities, support Risk Based Monitoring (RBM) activities, assess data collection and (regulatory) document collection, perform remote activities for investigational sites in accordance with corporate, sponsor and regulatory (ICH GCP and other) standards and guidelines. Represents the corporation by maintaining collaborative relationships with stakeholders.</span></div>","descriptionBodyPlain":"This position will support and observe clinical site monitoring services inhouse and provide monitoring and site management activities for full-service studies assessing for protocol, SOP and regulatory compliance. Responsibilities include site management activities to help drive investigative sites and patient recruitment, compliance and oversight.  Conduct remote data review, support data query and closure activities, support Risk Based Monitoring (RBM) activities, assess data collection and (regulatory) document collection, perform remote activities for investigational sites in accordance with corporate, sponsor and regulatory (ICH GCP and other) standards and guidelines. Represents the corporation by maintaining collaborative relationships with stakeholders.\n","hostedUrl":"https://jobs.lever.co/alimentiv-2/f6aa613e-d295-474b-b901-513de6abb6c4","applyUrl":"https://jobs.lever.co/alimentiv-2/f6aa613e-d295-474b-b901-513de6abb6c4/apply"},{"additional":"","additionalPlain":"","categories":{"commitment":"Full-time, Permanent","location":"London, Ontario","team":"General - Talent Pools","allLocations":["London, Ontario"]},"createdAt":1766439663016,"descriptionPlain":"Don't see an opening that quite matches what you're looking for, or not ready to make a move yet? Let us know!\n \nWe are proactively inviting qualified candidates to join our talent pool for anticipated Clinical Operations Lead needs (COL & Sr. COL) to support our Clinical Monitoring team.\n","description":"<div>Don't see an opening that quite matches what you're looking for, or not ready to make a move yet? Let us know!</div>\n<div>&nbsp;</div>\n<div>We are proactively inviting qualified candidates to join our talent pool for anticipated Clinical Operations Lead needs (COL &amp; Sr. COL) to support our Clinical Monitoring team.</div>","id":"ad26a2f4-829f-4670-b222-c060527f37b8","lists":[{"text":"What the process looks like: ","content":"\n<li>A Talent Acquisition representative will contact selected candidates to schedule a qualifying call to learn more about your experience, and what your timeline looks like</li>\n<li>We'll also share details about timelines on our side - note that this Talent Pool is not necessarily for an immediate, active role</li>\n<li>We'll keep your details on file and in mind - if an active vacancy does arise which matches your seniority and logistical details, we'll reach out to get an interview scheduled with the team</li>\n"},{"text":"About the Role(s)","content":"\n<li><strong>Clinical Operations Lead </strong></li>\n<li>Provide overall oversight of regional CRAs to ensure site compliance with study protocols, ICH-GCP, local regulations, and project timelines.</li>\n<li>Lead and support monitoring activities, including co-monitoring visits and quality review of monitoring reports.</li>\n<li>Actively manage site, country, and regional performance (startup, recruitment, data quality, TMF, and timelines), escalating risks and issues as needed.</li>\n<li>Serve as the primary operational liaison between CRAs, project teams, and sponsors, delivering regular status updates and guidance.</li>\n<li>Train, mentor, and support CRAs on study-specific procedures, expectations, and performance standards.</li>\n<li>Oversee study startup, feasibility, and site management activities, including temporary direct site oversight when required.</li>\n<li>Contribute to project planning, financial oversight, and vendor coordination as applicable.</li>\n<li>Develop and deliver key study documents, tools, and presentations for sponsors, investigators, and study teams.</li>\n\n<div>&nbsp;</div>\n\n<li><strong>Senior Clinical Operations Lead </strong></li>\n<li>Provide strategic oversight of Clinical Operations Leads (COLs) and regional CRAs to ensure compliance with study protocols, ICH-GCP, local regulations, and timelines.</li>\n<li>Lead study-level monitoring and site management deliverables, including visit quality, recruitment, essential documents, and adherence to monitoring plans.</li>\n<li>Oversee country and site startup, feasibility, and vendor management activities, contributing to country/site selection strategy.</li>\n<li>Serve as the primary monitoring and site management liaison with sponsors, project teams, and internal stakeholders.</li>\n<li>Provide leadership, training, mentoring, and performance oversight for COLs and CRAs, including CRA assessments.</li>\n<li>Ensure high-quality, timely study execution, including financial oversight related to monitoring budgets, site payments, and pass-through costs.</li>\n<li>Contribute to or lead overall trial management for smaller or limited-scope clinical studies when required.</li>\n<li>Act as a subject matter expert, supporting process improvement initiatives, mentoring COLs, and representing Clinical Operations internally and externally.</li>\n"},{"text":"Qualifications (may vary depending on role needs)","content":"\n<li>COL - minimum 1 year experience + Honours Bachelor Degree</li>\n<li>Sr. COL - Minimum 3 years experience + Honours Bachelor Degree</li>\n"},{"text":"Compensation/Total Rewards","content":"\n<li>Compensation may vary depending on the role seniority, geographic location, and candidate experience.</li>\n<li>All full-time, permanent roles will include a base salary + eligibility for performance-based bonus, as well as a variety of benefits such as health, dental, RRSP matching, and more!</li>\n<li>If contacted for an initial call, a member of our TA team will be happy to share more.</li>\n"}],"text":"Join our Talent Pool - Clinical Operations Lead (Canada)","country":"CA","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>Don't see an opening that quite matches what you're looking for, or not ready to make a move yet? Let us know!</div>\n<div>&nbsp;</div>\n<div>We are proactively inviting qualified candidates to join our talent pool for anticipated Clinical Operations Lead needs (COL &amp; Sr. COL) to support our Clinical Monitoring team.</div>","descriptionBodyPlain":"Don't see an opening that quite matches what you're looking for, or not ready to make a move yet? Let us know!\n \nWe are proactively inviting qualified candidates to join our talent pool for anticipated Clinical Operations Lead needs (COL & Sr. COL) to support our Clinical Monitoring team.\n","hostedUrl":"https://jobs.lever.co/alimentiv-2/ad26a2f4-829f-4670-b222-c060527f37b8","applyUrl":"https://jobs.lever.co/alimentiv-2/ad26a2f4-829f-4670-b222-c060527f37b8/apply"},{"additional":"","additionalPlain":"","categories":{"commitment":"Full-time, Permanent","location":"Warsaw","team":"General - Talent Pools","allLocations":["Warsaw"]},"createdAt":1766439948032,"descriptionPlain":"Don't see an opening that quite matches what you're looking for, or not ready to make a move yet? Let us know!\n\nWe are proactively inviting qualified candidates to join our talent pool for anticipated Clinical Operations Lead needs (COL & Sr. COL) to support our Clinical Monitoring team. \n","description":"<div>Don't see an opening that quite matches what you're looking for, or not ready to make a move yet? Let us know!</div><div><br></div><div>We are proactively inviting qualified candidates to join our talent pool for anticipated Clinical Operations Lead needs (COL &amp; Sr. COL) to support our Clinical Monitoring team. </div>","id":"4069c1d8-ef09-4842-9464-743c14899b69","lists":[{"text":"What the process looks like: ","content":"<li>A Talent Acquisition representative will contact selected candidates to schedule a qualifying call to learn more about your experience, and what your timeline looks like</li><li>We'll also share details about timelines on our side - note that this Talent Pool is not necessarily for an immediate, active role</li><li>We'll keep your details on file and in mind - if an active vacancy does arise which matches your seniority and logistical details, we'll reach out to get an interview scheduled with the team</li>"},{"text":"About the Role(s)","content":"<li><b>Clinical Operations Lead </b></li><li>Provide overall oversight of regional CRAs to ensure site compliance with study protocols, ICH-GCP, local regulations, and project timelines.</li><li>Lead and support monitoring activities, including co-monitoring visits and quality review of monitoring reports.</li><li>Actively manage site, country, and regional performance (startup, recruitment, data quality, TMF, and timelines), escalating risks and issues as needed.</li><li>Serve as the primary operational liaison between CRAs, project teams, and sponsors, delivering regular status updates and guidance.</li><li>Train, mentor, and support CRAs on study-specific procedures, expectations, and performance standards.</li><li>Oversee study startup, feasibility, and site management activities, including temporary direct site oversight when required.</li><li>Contribute to project planning, financial oversight, and vendor coordination as applicable.</li><li>Develop and deliver key study documents, tools, and presentations for sponsors, investigators, and study teams.</li><div><br></div><li><b>Senior Clinical Operations Lead </b></li><li>Provide strategic oversight of Clinical Operations Leads (COLs) and regional CRAs to ensure compliance with study protocols, ICH-GCP, local regulations, and timelines.</li><li>Lead study-level monitoring and site management deliverables, including visit quality, recruitment, essential documents, and adherence to monitoring plans.</li><li>Oversee country and site startup, feasibility, and vendor management activities, contributing to country/site selection strategy.</li><li>Serve as the primary monitoring and site management liaison with sponsors, project teams, and internal stakeholders.</li><li>Provide leadership, training, mentoring, and performance oversight for COLs and CRAs, including CRA assessments.</li><li>Ensure high-quality, timely study execution, including financial oversight related to monitoring budgets, site payments, and pass-through costs.</li><li>Contribute to or lead overall trial management for smaller or limited-scope clinical studies when required.</li><li>Act as a subject matter expert, supporting process improvement initiatives, mentoring COLs, and representing Clinical Operations internally and externally.</li>"},{"text":"Qualifications (may vary depending on role needs)","content":"<li>COL - minimum 1 year experience  + Honours Bachelor Degree</li><li>Sr. COL - Minimum 3 years experience + Honours Bachelor Degree</li>"},{"text":"Compensation/Total Rewards","content":"<li>Compensation may vary depending on the role seniority, geographic location, and candidate experience. </li><li>All full-time, permanent roles will include a base salary + eligibility for performance-based bonus, as well as a variety of benefits such as health, dental, and more!</li><li>If contacted for an initial call, a member of our TA team will be happy to share more. </li>"}],"text":"Join our Talent Pool - Clinical Operations Lead (Europe)","country":"PL","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>Don't see an opening that quite matches what you're looking for, or not ready to make a move yet? Let us know!</div><div><br></div><div>We are proactively inviting qualified candidates to join our talent pool for anticipated Clinical Operations Lead needs (COL &amp; Sr. COL) to support our Clinical Monitoring team. </div>","descriptionBodyPlain":"Don't see an opening that quite matches what you're looking for, or not ready to make a move yet? Let us know!\n\nWe are proactively inviting qualified candidates to join our talent pool for anticipated Clinical Operations Lead needs (COL & Sr. COL) to support our Clinical Monitoring team. \n","hostedUrl":"https://jobs.lever.co/alimentiv-2/4069c1d8-ef09-4842-9464-743c14899b69","applyUrl":"https://jobs.lever.co/alimentiv-2/4069c1d8-ef09-4842-9464-743c14899b69/apply"},{"additionalPlain":"Stay Alert to Recruitment Scams\nWe have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.\n","additional":"<div><span data-teams=\"true\"><strong>Stay Alert to Recruitment Scams</strong><br>We have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.</span></div>","categories":{"commitment":"Full-time, Permanent","location":"London, Ontario","team":"General - Talent Pools","allLocations":["London, Ontario"]},"createdAt":1766435473669,"descriptionPlain":"Don't see an opening that quite matches what you're looking for, or not ready to make a move yet? Let us know!\n \nWe are proactively inviting qualified candidates to join our talent pool for anticipated Clinical Research Associate needs (across multiple seniority levels) to support our Clinical Monitoring team.\n \n \n","description":"<div>Don't see an opening that quite matches what you're looking for, or not ready to make a move yet? Let us know!</div>\n<div>&nbsp;</div>\n<div>We are proactively inviting qualified candidates to join our talent pool for anticipated Clinical Research Associate needs (across multiple seniority levels) to support our Clinical Monitoring team.</div>\n<div>&nbsp;</div>\n<div>&nbsp;</div>","id":"7aef54d9-8075-480c-8f43-926812648a82","lists":[{"text":"What the process looks like: ","content":"\n<li>&nbsp;A Talent Acquisition representative will contact selected candidates to schedule a qualifying call to learn more about your experience, and what your timeline looks like</li>\n<li>We'll also share details about timelines on our side - note that this Talent Pool is not necessarily for an immediate, active role</li>\n<li>We'll keep your details on file and in mind - if an active vacancy does arise which matches your seniority and logistical details, we'll reach out to get an interview scheduled with the team</li>\n\n<div>&nbsp;</div>"},{"text":"About the Role(s)","content":"\n<li><strong>Clinical Research Associate I/II</strong></li>\n<li>Support/conduct (as appropriate) site management through remote and supervised onsite visits (initiation, monitoring, and close-out) in compliance with SOPs, protocol, and GCP.</li>\n<li>Perform remote data and system reviews (EDC, CTMS, RBM, TMF) to ensure data quality, completeness, and regulatory compliance.</li>\n<li>Assist/lead (as appropriate) with query resolution, safety reviews, and adverse event follow-up throughout the study lifecycle.</li>\n<li>Support/conduct (as appropriate) site startup and activation activities, including investigator coordination, trial material delivery, and recruitment support.</li>\n<li>Maintain accurate, timely, and complete TMF documentation, requesting updates as required.</li>\n<li>Provide day-to-day operational support to Senior CRA, and Lead CRAs.</li>\n<li>Participate in training, study meetings, and CRA development activities, building competencies required for role progression.</li>\n\n<div>&nbsp;</div>\n\n<li><strong>Sr. Clinical Research Associate</strong></li>\n\n<div>As above, with the addition of the following:</div>\n\n<li>Act as subject matter expert, mentor, coach and/or provide performance feedback to manager for peers.</li>\n<li>Assist with selection, hiring, training, and supervision of CRAs as needed. Perform co-monitoring and training visits with CRAs.&nbsp;</li>\n<li>When required, act as the first escalation point for the resolution of site/patient issues or to address Sponsor concerns.</li>\n<li>May represent Director, Monitoring and Site Management or Manager, Clinical Site Management in BD initiatives with a site monitoring focus.</li>\n<li>May be assigned Lead CRA role and manage monitoring services for a group of projects and/or CRAs on large/complex project(s) including directing/guiding day to day activities and review/approval of monitoring reports.</li>\n<li>Oversee overall integrity of the study to promote positive working relationships with the site and staff.</li>\n<li>Ensure SOPs in place to optimize patient recruitment providing guidance to site teams of inclusion/exclusion criteria.</li>\n"},{"text":"Qualifications (may vary depending on role needs)","content":"\n<li>CRA I - minimum 1 year experience + Honours Bachelor Degree</li>\n<li>CRA II - Minimum 2 years experience + Honours Bachelor Degree</li>\n<li>Sr. CRA - Minimum 3 years experience + Honours Bachelor Degree</li>\n"},{"text":"Compensation/Total Rewards","content":"\n<li>Compensation may vary depending on the role seniority, geographic location, and candidate experience.</li>\n<li>All full-time, permanent roles will include a base salary + elgibility for performance-based bonus, as well as a variety of health, dental, RRSP matching, and more!</li>\n<li>If contacted for an initial call, a member of our TA team will be happy to share more.</li>\n"}],"text":"Join our Talent Pool - Clinical Research Associates (Canada)","country":"CA","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>Don't see an opening that quite matches what you're looking for, or not ready to make a move yet? Let us know!</div>\n<div>&nbsp;</div>\n<div>We are proactively inviting qualified candidates to join our talent pool for anticipated Clinical Research Associate needs (across multiple seniority levels) to support our Clinical Monitoring team.</div>\n<div>&nbsp;</div>\n<div>&nbsp;</div>","descriptionBodyPlain":"Don't see an opening that quite matches what you're looking for, or not ready to make a move yet? Let us know!\n \nWe are proactively inviting qualified candidates to join our talent pool for anticipated Clinical Research Associate needs (across multiple seniority levels) to support our Clinical Monitoring team.\n \n \n","hostedUrl":"https://jobs.lever.co/alimentiv-2/7aef54d9-8075-480c-8f43-926812648a82","applyUrl":"https://jobs.lever.co/alimentiv-2/7aef54d9-8075-480c-8f43-926812648a82/apply"},{"additionalPlain":"Stay Alert to Recruitment Scams\nWe have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.\n","additional":"<div><span data-teams=\"true\"><strong>Stay Alert to Recruitment Scams</strong><br>We have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.</span></div>","categories":{"commitment":"Full-time, Permanent","location":"Budapest","team":"General - Talent Pools","allLocations":["Budapest","Vienna","Zagreb","Vilnius"]},"createdAt":1772548292967,"descriptionPlain":"Don't see an opening that quite matches what you're looking for, or not ready to make a move yet? Let us know!\n \nWe are proactively inviting qualified candidates to join our talent pool for anticipated Clinical Research Associate needs (across multiple seniority levels) to support our Clinical Monitoring team.\n \n \n","description":"<div>Don't see an opening that quite matches what you're looking for, or not ready to make a move yet? Let us know!</div>\n<div>&nbsp;</div>\n<div>We are proactively inviting qualified candidates to join our talent pool for anticipated Clinical Research Associate needs (across multiple seniority levels) to support our Clinical Monitoring team.</div>\n<div>&nbsp;</div>\n<div>&nbsp;</div>","id":"68e7f64f-78c8-4d4a-be44-7f4d74ac27bb","lists":[{"text":"What the process looks like: ","content":"\n<li>&nbsp;A Talent Acquisition representative will contact selected candidates to schedule a qualifying call to learn more about your experience, and what your timeline looks like</li>\n<li>We'll also share details about timelines on our side - note that this Talent Pool is not necessarily for an immediate, active role</li>\n<li>We'll keep your details on file and in mind - if an active vacancy does arise which matches your seniority and logistical details, we'll reach out to get an interview scheduled with the team</li>\n\n<div>&nbsp;</div>"},{"text":"About the Role(s)","content":"\n<li><strong>Clinical Research Associate I/II</strong></li>\n<li>Support/conduct (as appropriate) site management through remote and supervised onsite visits (initiation, monitoring, and close-out) in compliance with SOPs, protocol, and GCP.</li>\n<li>Perform remote data and system reviews (EDC, CTMS, RBM, TMF) to ensure data quality, completeness, and regulatory compliance.</li>\n<li>Assist/lead (as appropriate) with query resolution, safety reviews, and adverse event follow-up throughout the study lifecycle.</li>\n<li>Support/conduct (as appropriate) site startup and activation activities, including investigator coordination, trial material delivery, and recruitment support.</li>\n<li>Maintain accurate, timely, and complete TMF documentation, requesting updates as required.</li>\n<li>Provide day-to-day operational support to Senior CRA, and Lead CRAs.</li>\n<li>Participate in training, study meetings, and CRA development activities, building competencies required for role progression.</li>\n\n<div>&nbsp;</div>\n\n<li><strong>Sr. Clinical Research Associate</strong></li>\n\n<div>As above, with the addition of the following:</div>\n\n<li>Act as subject matter expert, mentor, coach and/or provide performance feedback to manager for peers.</li>\n<li>Assist with selection, hiring, training, and supervision of CRAs as needed. Perform co-monitoring and training visits with CRAs.&nbsp;</li>\n<li>When required, act as the first escalation point for the resolution of site/patient issues or to address Sponsor concerns.</li>\n<li>May represent Director, Monitoring and Site Management or Manager, Clinical Site Management in BD initiatives with a site monitoring focus.</li>\n<li>May be assigned Lead CRA role and manage monitoring services for a group of projects and/or CRAs on large/complex project(s) including directing/guiding day to day activities and review/approval of monitoring reports.</li>\n<li>Oversee overall integrity of the study to promote positive working relationships with the site and staff.</li>\n<li>Ensure SOPs in place to optimize patient recruitment providing guidance to site teams of inclusion/exclusion criteria.</li>\n"},{"text":"Qualifications (may vary depending on role needs)","content":"\n<li>CRA I - minimum 1 year experience + Honours Bachelor Degree</li>\n<li>CRA II - Minimum 2 years experience + Honours Bachelor Degree</li>\n<li>Sr. CRA - Minimum 3 years experience + Honours Bachelor Degree</li>\n"},{"text":"Compensation/Total Rewards","content":"\n<li>Compensation may vary depending on the role seniority, geographic location, and candidate experience.</li>\n<li>All full-time, permanent roles will include a base salary + elgibility for performance-based bonus, as well as a variety of health, dental, RRSP matching, and more!</li>\n<li>If contacted for an initial call, a member of our TA team will be happy to share more.</li>\n"}],"text":"Join our Talent Pool - Clinical Research Associates (Eastern Europe)","country":"HU","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>Don't see an opening that quite matches what you're looking for, or not ready to make a move yet? Let us know!</div>\n<div>&nbsp;</div>\n<div>We are proactively inviting qualified candidates to join our talent pool for anticipated Clinical Research Associate needs (across multiple seniority levels) to support our Clinical Monitoring team.</div>\n<div>&nbsp;</div>\n<div>&nbsp;</div>","descriptionBodyPlain":"Don't see an opening that quite matches what you're looking for, or not ready to make a move yet? Let us know!\n \nWe are proactively inviting qualified candidates to join our talent pool for anticipated Clinical Research Associate needs (across multiple seniority levels) to support our Clinical Monitoring team.\n \n \n","hostedUrl":"https://jobs.lever.co/alimentiv-2/68e7f64f-78c8-4d4a-be44-7f4d74ac27bb","applyUrl":"https://jobs.lever.co/alimentiv-2/68e7f64f-78c8-4d4a-be44-7f4d74ac27bb/apply"},{"additionalPlain":"Stay Alert to Recruitment Scams\nWe have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.\n","additional":"<div><span data-teams=\"true\"><strong>Stay Alert to Recruitment Scams</strong><br>We have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.</span></div>","categories":{"commitment":"Full-time, Permanent","location":"Krakow","team":"General - Talent Pools","allLocations":["Krakow","Bucharest","Brussels","Berlin","London"]},"createdAt":1767641370918,"descriptionPlain":"Don't see an opening that quite matches what you're looking for, or not ready to make a move yet? Let us know!\n \nWe are proactively inviting qualified candidates to join our talent pool for anticipated Clinical Research Associate needs (across multiple seniority levels) to support our Clinical Monitoring team.\n \n \n","description":"<div>Don't see an opening that quite matches what you're looking for, or not ready to make a move yet? Let us know!</div>\n<div>&nbsp;</div>\n<div>We are proactively inviting qualified candidates to join our talent pool for anticipated Clinical Research Associate needs (across multiple seniority levels) to support our Clinical Monitoring team.</div>\n<div>&nbsp;</div>\n<div>&nbsp;</div>","id":"3ec75ff0-8b9f-4c1f-a87f-b4667d779d82","lists":[{"text":"What the process looks like: ","content":"\n<li>&nbsp;A Talent Acquisition representative will contact selected candidates to schedule a qualifying call to learn more about your experience, and what your timeline looks like</li>\n<li>We'll also share details about timelines on our side - note that this Talent Pool is not necessarily for an immediate, active role</li>\n<li>We'll keep your details on file and in mind - if an active vacancy does arise which matches your seniority and logistical details, we'll reach out to get an interview scheduled with the team</li>\n\n<div>&nbsp;</div>"},{"text":"About the Role(s)","content":"\n<li><strong>Clinical Research Associate I/II</strong></li>\n<li>Support/conduct (as appropriate) site management through remote and supervised onsite visits (initiation, monitoring, and close-out) in compliance with SOPs, protocol, and GCP.</li>\n<li>Perform remote data and system reviews (EDC, CTMS, RBM, TMF) to ensure data quality, completeness, and regulatory compliance.</li>\n<li>Assist/lead (as appropriate) with query resolution, safety reviews, and adverse event follow-up throughout the study lifecycle.</li>\n<li>Support/conduct (as appropriate) site startup and activation activities, including investigator coordination, trial material delivery, and recruitment support.</li>\n<li>Maintain accurate, timely, and complete TMF documentation, requesting updates as required.</li>\n<li>Provide day-to-day operational support to Senior CRA, and Lead CRAs.</li>\n<li>Participate in training, study meetings, and CRA development activities, building competencies required for role progression.</li>\n\n<div>&nbsp;</div>\n\n<li><strong>Sr. Clinical Research Associate</strong></li>\n\n<div>As above, with the addition of the following:</div>\n\n<li>Act as subject matter expert, mentor, coach and/or provide performance feedback to manager for peers.</li>\n<li>Assist with selection, hiring, training, and supervision of CRAs as needed. Perform co-monitoring and training visits with CRAs.&nbsp;</li>\n<li>When required, act as the first escalation point for the resolution of site/patient issues or to address Sponsor concerns.</li>\n<li>May represent Director, Monitoring and Site Management or Manager, Clinical Site Management in BD initiatives with a site monitoring focus.</li>\n<li>May be assigned Lead CRA role and manage monitoring services for a group of projects and/or CRAs on large/complex project(s) including directing/guiding day to day activities and review/approval of monitoring reports.</li>\n<li>Oversee overall integrity of the study to promote positive working relationships with the site and staff.</li>\n<li>Ensure SOPs in place to optimize patient recruitment providing guidance to site teams of inclusion/exclusion criteria.</li>\n"},{"text":"Qualifications (may vary depending on role needs)","content":"\n<li>CRA I - minimum 1 year experience + Honours Bachelor Degree</li>\n<li>CRA II - Minimum 2 years experience + Honours Bachelor Degree</li>\n<li>Sr. CRA - Minimum 3 years experience + Honours Bachelor Degree</li>\n"},{"text":"Compensation/Total Rewards","content":"\n<li>Compensation may vary depending on the role seniority, geographic location, and candidate experience.</li>\n<li>All full-time, permanent roles will include a base salary + elgibility for performance-based bonus, as well as a variety of health, dental, RRSP matching, and more!</li>\n<li>If contacted for an initial call, a member of our TA team will be happy to share more.</li>\n"}],"text":"Join our Talent Pool - Clinical Research Associates (Europe)","country":"PL","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>Don't see an opening that quite matches what you're looking for, or not ready to make a move yet? Let us know!</div>\n<div>&nbsp;</div>\n<div>We are proactively inviting qualified candidates to join our talent pool for anticipated Clinical Research Associate needs (across multiple seniority levels) to support our Clinical Monitoring team.</div>\n<div>&nbsp;</div>\n<div>&nbsp;</div>","descriptionBodyPlain":"Don't see an opening that quite matches what you're looking for, or not ready to make a move yet? Let us know!\n \nWe are proactively inviting qualified candidates to join our talent pool for anticipated Clinical Research Associate needs (across multiple seniority levels) to support our Clinical Monitoring team.\n \n \n","hostedUrl":"https://jobs.lever.co/alimentiv-2/3ec75ff0-8b9f-4c1f-a87f-b4667d779d82","applyUrl":"https://jobs.lever.co/alimentiv-2/3ec75ff0-8b9f-4c1f-a87f-b4667d779d82/apply"},{"additional":"","additionalPlain":"","categories":{"commitment":"Full-time, Permanent","location":"Munich","team":"General - Talent Pools","allLocations":["Munich"]},"createdAt":1766440172382,"descriptionPlain":"Don't see an opening that quite matches what you're looking for, or not ready to make a move yet? Let us know!\n\nWe are proactively inviting qualified candidates to join our talent pool for anticipated Project Management needs (across multiple seniority levels from Project Managers (PM) to Project Directors (PD)). At Alimentiv, we have project management teams in Full-Service Study Management, Imaging, as well as supporting roles in Corporate Services. At this time, we're primarily seeking those with clinical project management experience at the PM or PD level. \n\n\n","description":"<div>Don't see an opening that quite matches what you're looking for, or not ready to make a move yet? Let us know!</div><div><br></div><div>We are proactively inviting qualified candidates to join our talent pool for anticipated Project Management needs (across multiple seniority levels from Project Managers (PM) to Project Directors (PD)). At Alimentiv, we have project management teams in Full-Service Study Management, Imaging, as well as supporting roles in Corporate Services. At this time, we're primarily seeking those with clinical project management experience at the PM or PD level. </div><div><br></div><div><br></div>","id":"0253fd80-4090-4b39-b3e9-2c4b2e264547","lists":[{"text":"What the process looks like: ","content":"<li>&nbsp;A Talent Acquisition representative will contact selected candidates to schedule a qualifying call to learn more about your experience, and what your timeline looks like</li><li>We'll also share details about timelines on our side - note that this Talent Pool is not necessarily for an immediate, active role</li><li>We'll keep your details on file and in mind - if an active vacancy does arise which matches your seniority and logistical details, we'll reach out to get an interview scheduled with the team</li><li>Our Talent team is actively monitoring this pool - no black box here! </li><div><br></div>"},{"text":"About the Role(s)","content":"<li><b>Project Manager</b></li><div><br></div><li>As the project lead, will act as primary liaison throughout the project life cycle ensuring client/sponsor expectations appropriately managed; addressing and resolving queries/issues, planning and executing all project meetings, assisting with site and patient recruitment strategies and materials, assisting with the development of stakeholder training and by regularly providing sponsor/client with project status and update reports.</li><li>Manage project budget and initiate, review and negotiate changes to study budgets with sponsor.</li><li>Identify, assign and monitor the completion of interdisciplinary project tasks.</li><li>Develop and/or participate in the development of project communications, training, regulatory submissions and/or audits and selection of third party vendors as required.</li><li>Define and manage project resource needs and establish contingency plans for key resources.</li><li>Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects.</li><li>Ensure that staff allocated to assigned project adheres to professional standards and SOPs established for clinical research.</li><li>Lead, motivate and coordinate teams and mentor/coach team members as appropriate.</li><li>Delegate effectively and prioritize own and project team members workload.</li><div><br></div><li><b>Project Director</b></li><div><br></div><div><i>As above, with the addition of the following:</i></div><li>Establish and maintain high quality, well-functioning client relationships throughout project life cycle, working with client(s) and CPMs to establish delivery expectations, metric, and communication standards.</li><li>Ensuring client remains well informed on project progress, risks, issues and changing needs and that clients' queries are appropriately addressed and resolved in a timely manner, within established project guidelines/standards.</li><li>When required assist with RFP/bid defense processes.</li><li> Working with CPMs and other functional specialists to deliver high quality projects that include all required elements within pre-established corporate standards.</li><li>Review and approve project scope, budget, metrics, tools, recruitment, and training requirements with CPM ensuring all project elements are in place, are realistic, are completed and delivered, and adhere to all project and regulatory requirements.</li><li>Oversee and review project critical path(s) providing guidance and regular feedback to Clinical Project Managers to ensure process aligns with client expectations, that project SOPs, controls, guidelines, regulatory standards, and industry best practice are being met or exceeded, and that consistent high quality service level is maintained from internal and third-party providers throughout the project life cycle.</li><li>Evaluate, assign, and monitor unit resource requirements to ensure all current and upcoming projects are planned, staffed and resourced appropriately and that staff and third-party vendor performance meets or exceeds sponsor, project and regulatory expectation.</li><li> This will include hiring, terminations, performance evaluations, staff training and development activities and providing input to the director during the corporate budget process.</li>"},{"text":"Qualifications (may vary depending on role needs)","content":"<li><b>Project Manager </b>- Applicants should have a minimum of a college diploma/degree and 3-5 years of relevant experience + substantial on-going training. The ideal candidate will have people management experience&nbsp;and possess significant and progressive experience in the management of global, multi-centre, investigator-initiated clinical trials. The successful individual will demonstrate exceptional communication and time management skills.</li><li><b>Project Directo</b>r - Applicants should have a minimum of seven years of related work experience with ongoing training, and a three-year College Advance Diploma/Degree in a relevant field of study, preferable in (Health) Sciences or Clinical Research. </li><div><br></div>"},{"text":"Compensation/Total Rewards","content":"<li>Compensation may vary depending on the role seniority, geographic location, and candidate experience. </li><li>All full-time, permanent roles will include a base salary + eligibility for performance-based bonus, as well as a variety of benefits which vary by location, but are designed to ensure you feel supported.</li><li>If contacted for an initial call, a member of our TA team will be happy to share more. </li>"}],"text":"Join our Talent Pool - Project Management (Europe)","country":"DE","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>Don't see an opening that quite matches what you're looking for, or not ready to make a move yet? Let us know!</div><div><br></div><div>We are proactively inviting qualified candidates to join our talent pool for anticipated Project Management needs (across multiple seniority levels from Project Managers (PM) to Project Directors (PD)). At Alimentiv, we have project management teams in Full-Service Study Management, Imaging, as well as supporting roles in Corporate Services. At this time, we're primarily seeking those with clinical project management experience at the PM or PD level. </div><div><br></div><div><br></div>","descriptionBodyPlain":"Don't see an opening that quite matches what you're looking for, or not ready to make a move yet? Let us know!\n\nWe are proactively inviting qualified candidates to join our talent pool for anticipated Project Management needs (across multiple seniority levels from Project Managers (PM) to Project Directors (PD)). At Alimentiv, we have project management teams in Full-Service Study Management, Imaging, as well as supporting roles in Corporate Services. At this time, we're primarily seeking those with clinical project management experience at the PM or PD level. \n\n\n","hostedUrl":"https://jobs.lever.co/alimentiv-2/0253fd80-4090-4b39-b3e9-2c4b2e264547","applyUrl":"https://jobs.lever.co/alimentiv-2/0253fd80-4090-4b39-b3e9-2c4b2e264547/apply"},{"additionalPlain":"PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report. \n","additional":"<div>PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.&nbsp;</div>","categories":{"commitment":"Full-time, Permanent","department":"Clinical Services","location":"Gdansk","team":"Clinical Study Delivery - Monitoring & Site Management","allLocations":["Gdansk","Krakow","Warsaw","Budapest","Bucharest","Berlin","Frankfurt","London","Belfast","Cambridge","Dublin"]},"createdAt":1780100443425,"descriptionPlain":"ABOUT ALIMENTIV\nAlimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.\nWe operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.\nIf you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you.\nTHE OPPORTUNITY\nIn this role, you will lead the day-to-day delivery of our Clinical Monitoring capability, with a focus on European CRAs. You will bring structure, clarity, and accountability to how we plan, manage, and continuously improve this critical function.\nYour scope spans both operational leadership and strategic impact. From shaping policies and strengthening processes, to ensuring the quality and integrity of our clinical work at every level, you will play a central role. You will oversee resource planning, performance management, and compliance, ensuring our teams and partners deliver consistently high standards aligned with both regulatory expectations and industry best practice.\nWorking closely with sponsors and research partners, you will act as a trusted representative of our clinical monitoring and project teams throughout the full study lifecycle. You will bring expertise, credibility, and a solutions-oriented mindset to every interaction.\nPositions available: 1; this opportunity is cross-listed in multiple locations. At this time, the position is open to those residing in Germany, United Kingdom, Ireland, Poland, Hungary, and Romania. \nClosing date: June 12th, 2026, or later until successful candidate identified. \n","description":"<div>\n<p><strong>ABOUT ALIMENTIV</strong></p>\n<p>Alimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.</p>\n<p>We operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.</p>\n<p>If you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you.</p>\n<p><strong>THE OPPORTUNITY</strong></p>\n<p>In this role, you will lead the day-to-day delivery of our Clinical Monitoring capability, with a focus on European CRAs. You will bring structure, clarity, and accountability to how we plan, manage, and continuously improve this critical function.</p>\n<p>Your scope spans both operational leadership and strategic impact. From shaping policies and strengthening processes, to ensuring the quality and integrity of our clinical work at every level, you will play a central role. You will oversee resource planning, performance management, and compliance, ensuring our teams and partners deliver consistently high standards aligned with both regulatory expectations and industry best practice.</p>\n<p>Working closely with sponsors and research partners, you will act as a trusted representative of our clinical monitoring and project teams throughout the full study lifecycle. You will bring expertise, credibility, and a solutions-oriented mindset to every interaction.</p>\n<div><strong>Positions available</strong>: 1; this opportunity is cross-listed in multiple locations. At this time, the position is open to those residing in Germany, United Kingdom, Ireland, Poland, Hungary, and Romania.&nbsp;</div>\n<div><strong>Closing date</strong>: June 12th, 2026, or later until successful candidate identified.&nbsp;</div>\n</div>","id":"3ebbdd55-e588-4668-aca4-24d2619c25f5","lists":[{"text":"Project Planning","content":"\n<li>Working in conjunction with clinical monitoring and project leadership team members, identify, develop, plan for, monitor, approve and/or report on project specific processes and services related to site selection, clinical monitoring, ICH-GCP compliance issue resolution, and global project harmonization including SOP and QS document maintenance, periodic site visits and collaborating with IT support to meet sponsor requirements on a timely basis.</li>\n"},{"text":"Customer Service Delivery","content":"\n<li>Represent and support the Clinical Monitoring teams with internal partners and external Sponsors to identify areas of improvement, to address sponsor/site concerns and to integrate new technologies and processes.&nbsp;</li>\n<li>Ensure regulatory compliance, industry best practices, and organizational goals and targets are met and/or exceeded.</li>\n"},{"text":"Team Management and Engagement","content":"\n<li>Manage members of the Clinical Monitoring teams, ensuring functional areas are adequately staffed with qualified personnel, providing ongoing support to staff in the areas of work allocation, resource planning, training and development, technology, process development, expense management, employee engagement and performance management (staff role development, evaluations, performance improvement and lost time management).</li>\n\n<div>&nbsp;</div>"},{"text":"Third Party Contract Management","content":"\n<li>Identify, procure, and manage Clinical Monitoring (Clinical Operations Leads) Independent Contractor services, including needs assessment, recruitment, contract negotiations, Corporate and Sponsor policy compliance, training and development, cost monitoring and performance management, ensuring corporate, industry and regulatory service level, guidelines and regulations are maintained.</li>\n"},{"text":"Product/Service Delivery Support","content":"\n<li>Provide expertise, developing tools to support project teams and business development in the areas of clinical, site and compliance monitoring and performance during the project life cycle starting from the bidding process through to reporting project findings to sponsors.</li>\n"},{"text":"Qualifications ","content":"\n<li>The successful candidate should have a College Diploma/University Degree in a relevant field (Health Sciences, Life Sciences preferred, or SoCRA and/or ACRP Certification/Designation) and a minimum of 4-6 years related experience + substantial on-going training.</li>\n<li>Experience in managing CRA staff and ability to provide training and/or mentorship to colleagues on a 1:1 basis or meeting setting.</li>\n<li>Ability to work in a remote global capacity</li>\n<li>Strong knowledge of appropriate regulations and guidelines as they pertain to clinical monitoring and GCP.</li>\n<li>Team player that has a customer service approach and is solution oriented.</li>\n<li>Demonstrated leadership skills</li>\n<li>Strong verbal, written, and organizational skills.</li>\n<li>Ability to handle multiple tasks to meet deadlines in a dynamic environment.</li>\n\n<div>&nbsp;</div>"},{"text":"Working Conditions ","content":"\n<li>Home-based</li>\n"}],"salaryRange":{"currency":"EUR","interval":"per-year-salary","min":76500,"max":127500},"salaryDescription":"<div>+ bonus</div>\n<div>&nbsp;</div>\n<div>\n<div>&nbsp;</div>\n<div>Please note that the above range reflects the full spectrum of compensation for candidates located in Germany - our Talent Acquisition team will be happy to discuss specific local compensation at time of interview.&nbsp;</div>\n</div>","salaryDescriptionPlain":"+ bonus\n \n \nPlease note that the above range reflects the full spectrum of compensation for candidates located in Germany - our Talent Acquisition team will be happy to discuss specific local compensation at time of interview. \n","text":"Manager, Monitoring & Site Management","country":"PL","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>\n<p><strong>ABOUT ALIMENTIV</strong></p>\n<p>Alimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.</p>\n<p>We operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.</p>\n<p>If you want to do meaningful work, build something real, and invest back in research that changes lives &mdash; we want to meet you.</p>\n<p><strong>THE OPPORTUNITY</strong></p>\n<p>In this role, you will lead the day-to-day delivery of our Clinical Monitoring capability, with a focus on European CRAs. You will bring structure, clarity, and accountability to how we plan, manage, and continuously improve this critical function.</p>\n<p>Your scope spans both operational leadership and strategic impact. From shaping policies and strengthening processes, to ensuring the quality and integrity of our clinical work at every level, you will play a central role. You will oversee resource planning, performance management, and compliance, ensuring our teams and partners deliver consistently high standards aligned with both regulatory expectations and industry best practice.</p>\n<p>Working closely with sponsors and research partners, you will act as a trusted representative of our clinical monitoring and project teams throughout the full study lifecycle. You will bring expertise, credibility, and a solutions-oriented mindset to every interaction.</p>\n<div><strong>Positions available</strong>: 1; this opportunity is cross-listed in multiple locations. At this time, the position is open to those residing in Germany, United Kingdom, Ireland, Poland, Hungary, and Romania.&nbsp;</div>\n<div><strong>Closing date</strong>: June 12th, 2026, or later until successful candidate identified.&nbsp;</div>\n</div>","descriptionBodyPlain":"ABOUT ALIMENTIV\nAlimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.\nWe operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.\nIf you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you.\nTHE OPPORTUNITY\nIn this role, you will lead the day-to-day delivery of our Clinical Monitoring capability, with a focus on European CRAs. You will bring structure, clarity, and accountability to how we plan, manage, and continuously improve this critical function.\nYour scope spans both operational leadership and strategic impact. From shaping policies and strengthening processes, to ensuring the quality and integrity of our clinical work at every level, you will play a central role. You will oversee resource planning, performance management, and compliance, ensuring our teams and partners deliver consistently high standards aligned with both regulatory expectations and industry best practice.\nWorking closely with sponsors and research partners, you will act as a trusted representative of our clinical monitoring and project teams throughout the full study lifecycle. You will bring expertise, credibility, and a solutions-oriented mindset to every interaction.\nPositions available: 1; this opportunity is cross-listed in multiple locations. At this time, the position is open to those residing in Germany, United Kingdom, Ireland, Poland, Hungary, and Romania. \nClosing date: June 12th, 2026, or later until successful candidate identified. \n","hostedUrl":"https://jobs.lever.co/alimentiv-2/3ebbdd55-e588-4668-aca4-24d2619c25f5","applyUrl":"https://jobs.lever.co/alimentiv-2/3ebbdd55-e588-4668-aca4-24d2619c25f5/apply"},{"additionalPlain":"Stay Alert to Recruitment Scams\nWe have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.\n","additional":"<div><span data-teams=\"true\"> <strong>Stay Alert to Recruitment Scams</strong><br>We have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.</span></div>","categories":{"commitment":"Full-time, Permanent","department":"Corporate Operations","location":"Raleigh-Durham, North Carolina","team":"Technology and Innovation","allLocations":["Raleigh-Durham, North Carolina"]},"createdAt":1772200804051,"descriptionPlain":"The Manager, Software Development & Testing is a hands-on people leader responsible for the day-to-day execution, quality, and delivery of software solutions within Alimentiv’s clinical imaging ecosystem. This role combines technical leadership with team management to ensure software is built, tested, and maintained in alignment with established architecture, regulatory expectations, and business priorities.\n \nActing as a player coach, the Manager contributes directly to development and testing activities while leading the team through effective planning, execution, and continuous improvement. The role focuses on reliable delivery across both legacy and modern platforms, balancing stability and innovation while collaborating closely with Product Management, Project Management, Solution Architecture, and other partner teams to meet evolving business and clinical needs.\n \n \n","description":"<div>The Manager, Software Development &amp; Testing is a hands-on people leader responsible for the day-to-day execution, quality, and delivery of software solutions within Alimentiv’s clinical imaging ecosystem. This role combines technical leadership with team management to ensure software is built, tested, and maintained in alignment with established architecture, regulatory expectations, and business priorities.</div>\n<div>&nbsp;</div>\n<div>Acting as a player coach, the Manager contributes directly to development and testing activities while leading the team through effective planning, execution, and continuous improvement. The role focuses on reliable delivery across both legacy and modern platforms, balancing stability and innovation while collaborating closely with Product Management, Project Management, Solution Architecture, and other partner teams to meet evolving business and clinical needs.</div>\n<div>&nbsp;</div>\n<div>&nbsp;</div>","id":"3a1afeff-5662-443d-aa16-0a922e43d21d","lists":[{"text":"Team Leadership & Delivery Oversight (30–35%)","content":"\n<li>Act as a player coach by mentoring, managing, and supporting software developers and testers while contributing selectively to hands-on delivery work as needed.</li>\n<li>Partner with Product Management and Project Management to support backlog readiness, clarify technical dependencies, and translate priorities into executable team plans.</li>\n<li>Perform people management responsibilities including coaching, performance feedback, development planning, and participation in hiring and onboarding.</li>\n<li>Monitor delivery health, risks, and dependencies, proactively addressing issues and escalating as needed to ensure predictable and reliable outcomes.</li>\n"},{"text":"Hardware & Firmware Integration Oversight (10–15%)","content":"\n<li>Provide technical oversight and coordination for software integration activities involving hardware and firmware components supporting clinical imaging solutions.</li>\n<li>Collaborate with hardware specialists, vendors, and partner teams to support integration, validation, troubleshooting, and issue resolution.</li>\n<li>Ensure software and hardware interactions meet reliability, compatibility, and compliance expectations within operational environments.</li>\n<li>Identify and escalate integration risks related to deployments, upgrades, and field operations to reduce disruption and operational impact.</li>\n"},{"text":"Process Improvement & Quality Assurance (10–15%)","content":"\n<li>Drive continuous improvement of development and software testing workflows, tools, and development practices to improve quality and delivery efficiency.</li>\n<li>Lead software QA testing activities, including test planning, execution, defect management, and test automation strategies.</li>\n<li>Monitor and act on quality indicators such as defect trends, test coverage, release stability, and post-release issues.</li>\n<li>Collaborate with Product Support and other partner teams to ensure effective defect resolution, root cause analysis, and sustained product stability.</li>\n"},{"text":"Cross-Functional Collaboration & Innovation (10%)","content":"\n<li>Collaborate with Product Management, Project Management, Solution Architecture, and other partner teams to align delivery execution with priorities and constraints.</li>\n<li>Communicate technical status, risks, and tradeoffs clearly to both technical and non-technical stakeholders.</li>\n<li>Stay informed on emerging technologies, tools, and practices relevant to clinical software delivery and testing.</li>\n<li>Encourage thoughtful adoption of new tools and practices that improve delivery efficiency, quality, and team effectiveness.</li>\n"},{"text":"Qualifications","content":"\n<li>7 – 9 years of related experience</li>\n<li>(Honors) Bachelor’s degree</li>\n<li>Fluent in written and verbal English</li>\n<li>Leadership &amp; People Management: 3+ years of experience managing and developing technical teams, including coaching, performance feedback, and participation in hiring and onboarding.</li>\n<li>Multi-Product Software Delivery: 3+ years of experience delivering and maintaining multiple production software products, including responsibility for coordinating development, testing, and release activities across distinct codebases.</li>\n<li>Application Development: 3+ years of hands-on experience building and supporting backend and frontend applications using modern programming languages, frameworks, and service-based or API-driven architectures.</li>\n<li>Platform &amp; Delivery Environments: 3+ years of experience delivering production systems across distinct technology stacks and deployment models in a managed delivery environment, with an emphasis on reliability, maintainability, and operational readiness.</li>\n<li>Quality Assurance &amp; Testing: 3+ years of experience leading or overseeing software QA testing activities, including automated testing strategies, execution, and release readiness.</li>\n<li>Technology Stack Adaptability: Demonstrated ability to work effectively within evolving technology ecosystems, balancing legacy platforms with modernized solutions and contributing to consolidation and standardization efforts.</li>\n<li>Hardware &amp; Firmware Integration: 2+ years of experience supporting software integration with hardware and firmware.</li>\n"},{"text":"Preferred","content":"\n<li>2+ years of experience delivering software in regulated environments such as GxP or GCP.</li>\n<li>2+ years of exposure to security, privacy, and compliance standards such as HIPAA, GDPR, or equivalent.</li>\n<li>Experience contributing to AI-enabled or data-driven applications in a clinical, research, or healthcare context.</li>\n<li>2+ years of experience implementing or expanding test automation within CI/CD pipelines.</li>\n<li>Familiarity with validation expectations for regulated clinical software systems.</li>\n"}],"salaryRange":{"min":95500,"max":159000,"currency":"USD","interval":"per-year-salary"},"text":"Manager, Software Development & Testing","country":"US","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>The Manager, Software Development &amp; Testing is a hands-on people leader responsible for the day-to-day execution, quality, and delivery of software solutions within Alimentiv&rsquo;s clinical imaging ecosystem. This role combines technical leadership with team management to ensure software is built, tested, and maintained in alignment with established architecture, regulatory expectations, and business priorities.</div>\n<div>&nbsp;</div>\n<div>Acting as a player coach, the Manager contributes directly to development and testing activities while leading the team through effective planning, execution, and continuous improvement. The role focuses on reliable delivery across both legacy and modern platforms, balancing stability and innovation while collaborating closely with Product Management, Project Management, Solution Architecture, and other partner teams to meet evolving business and clinical needs.</div>\n<div>&nbsp;</div>\n<div>&nbsp;</div>","descriptionBodyPlain":"The Manager, Software Development & Testing is a hands-on people leader responsible for the day-to-day execution, quality, and delivery of software solutions within Alimentiv’s clinical imaging ecosystem. This role combines technical leadership with team management to ensure software is built, tested, and maintained in alignment with established architecture, regulatory expectations, and business priorities.\n \nActing as a player coach, the Manager contributes directly to development and testing activities while leading the team through effective planning, execution, and continuous improvement. The role focuses on reliable delivery across both legacy and modern platforms, balancing stability and innovation while collaborating closely with Product Management, Project Management, Solution Architecture, and other partner teams to meet evolving business and clinical needs.\n \n \n","hostedUrl":"https://jobs.lever.co/alimentiv-2/3a1afeff-5662-443d-aa16-0a922e43d21d","applyUrl":"https://jobs.lever.co/alimentiv-2/3a1afeff-5662-443d-aa16-0a922e43d21d/apply"},{"additionalPlain":"Stay Alert to Recruitment Scams\nWe have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.\n","additional":"<div><span data-teams=\"true\"> <strong>Stay Alert to Recruitment Scams</strong><br>We have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.</span></div>","categories":{"commitment":"Full-time, Permanent","department":"Corporate Operations","location":"Toronto, Ontario","team":"Technology and Innovation","allLocations":["Toronto, Ontario"]},"createdAt":1772474386356,"descriptionPlain":"The Manager, Software Development & Testing is a hands-on people leader responsible for the day-to-day execution, quality, and delivery of software solutions within Alimentiv’s clinical imaging ecosystem. This role combines technical leadership with team management to ensure software is built, tested, and maintained in alignment with established architecture, regulatory expectations, and business priorities.\n \nActing as a player coach, the Manager contributes directly to development and testing activities while leading the team through effective planning, execution, and continuous improvement. The role focuses on reliable delivery across both legacy and modern platforms, balancing stability and innovation while collaborating closely with Product Management, Project Management, Solution Architecture, and other partner teams to meet evolving business and clinical needs.\n \n \n","description":"<div>The Manager, Software Development &amp; Testing is a hands-on people leader responsible for the day-to-day execution, quality, and delivery of software solutions within Alimentiv’s clinical imaging ecosystem. This role combines technical leadership with team management to ensure software is built, tested, and maintained in alignment with established architecture, regulatory expectations, and business priorities.</div>\n<div>&nbsp;</div>\n<div>Acting as a player coach, the Manager contributes directly to development and testing activities while leading the team through effective planning, execution, and continuous improvement. The role focuses on reliable delivery across both legacy and modern platforms, balancing stability and innovation while collaborating closely with Product Management, Project Management, Solution Architecture, and other partner teams to meet evolving business and clinical needs.</div>\n<div>&nbsp;</div>\n<div>&nbsp;</div>","id":"157461a4-edce-47d0-87a0-ede6f81589c7","lists":[{"text":"Team Leadership & Delivery Oversight (30–35%)","content":"\n<li>Act as a player coach by mentoring, managing, and supporting software developers and testers while contributing selectively to hands-on delivery work as needed.</li>\n<li>Partner with Product Management and Project Management to support backlog readiness, clarify technical dependencies, and translate priorities into executable team plans.</li>\n<li>Perform people management responsibilities including coaching, performance feedback, development planning, and participation in hiring and onboarding.</li>\n<li>Monitor delivery health, risks, and dependencies, proactively addressing issues and escalating as needed to ensure predictable and reliable outcomes.</li>\n"},{"text":"Hardware & Firmware Integration Oversight (10–15%)","content":"\n<li>Provide technical oversight and coordination for software integration activities involving hardware and firmware components supporting clinical imaging solutions.</li>\n<li>Collaborate with hardware specialists, vendors, and partner teams to support integration, validation, troubleshooting, and issue resolution.</li>\n<li>Ensure software and hardware interactions meet reliability, compatibility, and compliance expectations within operational environments.</li>\n<li>Identify and escalate integration risks related to deployments, upgrades, and field operations to reduce disruption and operational impact.</li>\n"},{"text":"Process Improvement & Quality Assurance (10–15%)","content":"\n<li>Drive continuous improvement of development and software testing workflows, tools, and development practices to improve quality and delivery efficiency.</li>\n<li>Lead software QA testing activities, including test planning, execution, defect management, and test automation strategies.</li>\n<li>Monitor and act on quality indicators such as defect trends, test coverage, release stability, and post-release issues.</li>\n<li>Collaborate with Product Support and other partner teams to ensure effective defect resolution, root cause analysis, and sustained product stability.</li>\n"},{"text":"Cross-Functional Collaboration & Innovation (10%)","content":"\n<li>Collaborate with Product Management, Project Management, Solution Architecture, and other partner teams to align delivery execution with priorities and constraints.</li>\n<li>Communicate technical status, risks, and tradeoffs clearly to both technical and non-technical stakeholders.</li>\n<li>Stay informed on emerging technologies, tools, and practices relevant to clinical software delivery and testing.</li>\n<li>Encourage thoughtful adoption of new tools and practices that improve delivery efficiency, quality, and team effectiveness.</li>\n"},{"text":"Qualifications","content":"\n<li>7 – 9 years of related experience</li>\n<li>(Honors) Bachelor’s degree</li>\n<li>Fluent in written and verbal English</li>\n<li>Leadership &amp; People Management: 3+ years of experience managing and developing technical teams, including coaching, performance feedback, and participation in hiring and onboarding.</li>\n<li>Multi-Product Software Delivery: 3+ years of experience delivering and maintaining multiple production software products, including responsibility for coordinating development, testing, and release activities across distinct codebases.</li>\n<li>Application Development: 3+ years of hands-on experience building and supporting backend and frontend applications using modern programming languages, frameworks, and service-based or API-driven architectures.</li>\n<li>Platform &amp; Delivery Environments: 3+ years of experience delivering production systems across distinct technology stacks and deployment models in a managed delivery environment, with an emphasis on reliability, maintainability, and operational readiness.</li>\n<li>Quality Assurance &amp; Testing: 3+ years of experience leading or overseeing software QA testing activities, including automated testing strategies, execution, and release readiness.</li>\n<li>Technology Stack Adaptability: Demonstrated ability to work effectively within evolving technology ecosystems, balancing legacy platforms with modernized solutions and contributing to consolidation and standardization efforts.</li>\n<li>Hardware &amp; Firmware Integration: 2+ years of experience supporting software integration with hardware and firmware.</li>\n"},{"text":"Preferred","content":"\n<li>2+ years of experience delivering software in regulated environments such as GxP or GCP.</li>\n<li>2+ years of exposure to security, privacy, and compliance standards such as HIPAA, GDPR, or equivalent.</li>\n<li>Experience contributing to AI-enabled or data-driven applications in a clinical, research, or healthcare context.</li>\n<li>2+ years of experience implementing or expanding test automation within CI/CD pipelines.</li>\n<li>Familiarity with validation expectations for regulated clinical software systems.</li>\n"}],"salaryRange":{"min":95500,"max":159000,"currency":"CAD","interval":"per-year-salary"},"text":"Manager, Software Development & Testing (Canada)","country":"CA","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>The Manager, Software Development &amp; Testing is a hands-on people leader responsible for the day-to-day execution, quality, and delivery of software solutions within Alimentiv&rsquo;s clinical imaging ecosystem. This role combines technical leadership with team management to ensure software is built, tested, and maintained in alignment with established architecture, regulatory expectations, and business priorities.</div>\n<div>&nbsp;</div>\n<div>Acting as a player coach, the Manager contributes directly to development and testing activities while leading the team through effective planning, execution, and continuous improvement. The role focuses on reliable delivery across both legacy and modern platforms, balancing stability and innovation while collaborating closely with Product Management, Project Management, Solution Architecture, and other partner teams to meet evolving business and clinical needs.</div>\n<div>&nbsp;</div>\n<div>&nbsp;</div>","descriptionBodyPlain":"The Manager, Software Development & Testing is a hands-on people leader responsible for the day-to-day execution, quality, and delivery of software solutions within Alimentiv’s clinical imaging ecosystem. This role combines technical leadership with team management to ensure software is built, tested, and maintained in alignment with established architecture, regulatory expectations, and business priorities.\n \nActing as a player coach, the Manager contributes directly to development and testing activities while leading the team through effective planning, execution, and continuous improvement. The role focuses on reliable delivery across both legacy and modern platforms, balancing stability and innovation while collaborating closely with Product Management, Project Management, Solution Architecture, and other partner teams to meet evolving business and clinical needs.\n \n \n","hostedUrl":"https://jobs.lever.co/alimentiv-2/157461a4-edce-47d0-87a0-ede6f81589c7","applyUrl":"https://jobs.lever.co/alimentiv-2/157461a4-edce-47d0-87a0-ede6f81589c7/apply"},{"additional":"","additionalPlain":"","categories":{"commitment":"Full-time, Limited term","department":"Corporate Operations","location":"Toronto, Ontario","team":"Technology and Innovation","allLocations":["Toronto, Ontario","Raleigh-Durham, North Carolina"]},"createdAt":1779367336835,"descriptionPlain":"The Manager, Veeva Vault Administration is responsible for the administration and operational delivery of the Veeva Vault platform, with a focus on Vault Clinical applications (eTMF, CTMS, Study Training, Study Startup, Site Connect). This role translates strategic technology priorities into practical system solutions and oversees their implementation and ongoing management. The administrator ensures business needs are captured and aligned through planning and coordination with cross-functional teams; configures and delivers system enhancements to meet operational requirements; maintains platform integrity, compliance, and data quality; and drives user success & adoption through training and responsive technical support. The role requires a high degree of self-management and initiative, with the ability to prioritize and execute tasks independently while collaborating effectively with operational teams and non-technical stakeholders.\n","description":"<div>The Manager, Veeva Vault Administration is responsible for the administration and operational delivery of the Veeva Vault platform, with a focus on Vault Clinical applications (eTMF, CTMS, Study Training, Study Startup, Site Connect). This role translates strategic technology priorities into practical system solutions and oversees their implementation and ongoing management. The administrator ensures business needs are captured and aligned through planning and coordination with cross-functional teams; configures and delivers system enhancements to meet operational requirements; maintains platform integrity, compliance, and data quality; and drives user success &amp; adoption through training and responsive technical support. The role requires a high degree of self-management and initiative, with the ability to prioritize and execute tasks independently while collaborating effectively with operational teams and non-technical stakeholders.</div>","id":"6f36f72a-5c75-436b-83bd-8bf77c67e0a8","lists":[{"text":"Vault Configuration & Solution Delivery (40-60%)","content":"\n<li>Collaborates with cross-functional stakeholders to gather, analyze, and translate business needs into actionable requirements &amp; specifications for Vault Clinical applications.</li>\n<li>Configures, validates, and implements Vault Clinical solutions across all applications, including workflows, lifecycles and metadata.</li>\n<li>Coordinates planning &amp; deployment of vendor platform updates, including evaluation of new features &amp; releases, impact analysis, readiness assessments, and production roll-out.</li>\n<li>Identifies and recommends innovative Vault Clinical enhancements aligned with Alimentiv’s strategic direction &amp; roadmap for the platform.</li>\n<li>Collaborates with business and technical stakeholders to execute data migrations and system integrations (e.g., EDC) connected to Veeva Vault.</li>\n<li>Ensures alignment and consistency of configurations across Vault Clinical applications, coordinating with delivery &amp; support staff to maintain a coherent architecture.&nbsp; &nbsp;&nbsp;</li>\n"},{"text":"Vault Maintenance, Security & Compliance (30-50%)","content":"\n<li>Maintains configuration of Vault Clinical applications (eTMF, CTMS, Study Training, Study Startup, Site Connect) and underlying Vault Platform data architecture (Global Directory).</li>\n<li>Manages system change requests, applying change controls in accordance with internal policies &amp; SOPs and external regulations.</li>\n<li>Manages user accounts &amp; permissions, applying role-based access principles and conducting user access reviews.</li>\n<li>Liaises with vendor support &amp; professional services for issue resolution and escalation when required.</li>\n<li>Oversees data governance of Vault Platform, monitoring data integrity and quality.</li>\n<li>Conducts system risk assessments and develops &amp; applies mitigations to ensure security, integrity and availability of the platform in accordance with GxP regulations (21 CFR Part 11, EMA) and ISO 27001 principles.</li>\n<li>Maintain system documentation, including validation deliverables, SOPs and work instructions, to ensure regulatory compliance and audit readiness.</li>\n"},{"text":"Vault User Enablement, Support & Training (10-25%)","content":"\n<li>Oversee user training and development &amp; maintenance of comprehensive training resources to drive user adoption and support effective system use.</li>\n<li>Provide technical support and guidance to internal and external Vault Clinical users, ensuring timely resolution of system issues and user inquiries.</li>\n<li>Serves as a trusted partner to non-technical users, ensuring clear communication and practical guidance to support adoption and effective use of the platform.</li>\n<li>Develop and maintain reports and dashboards for internal and external users leveraging Vault Clinical data to support operational visibility and decision-making.</li>\n"},{"text":"Team Management & Engagement (10-15%)","content":"\n<li>Formally supervise and oversee the work of internal Veeva solution delivery &amp; support staff.</li>\n<li>Assign and prioritize workloads to ensure timelines and quality expectations are met.</li>\n<li>Support recruitment activities, including onboarding and training new team members.</li>\n<li>Set, track, and evaluate performance objectives to align with departmental strategies.</li>\n<li>Conduct performance reviews and support team competency development.</li>\n<li>Provide conflict resolution support and maintain positive team morale.</li>\n<li>Monitor resourcing, capacity, and availability of staff, escalating concerns to Sr leadership as required</li>\n"},{"text":"Qualifications","content":"\n<li>7 – 9 years of related experience</li>\n<li>(Honors) Bachelor’s degree</li>\n<li>English fluency (written and verbal)&nbsp;</li>\n<li>Veeva Vault Platform Administrator or Veeva Clinical Operations Administrator certification is required, with demonstrated strong knowledge of Veeva configuration tools.</li>\n<li>Prior knowledge &amp; experience with configuration &amp; administration of Veeva Vault Clinical applications including eTMF, CTMS, Study Startup, Study Training, and Site Connect</li>\n<li>Knowledge of database management and data governance concepts &amp; principles for oversight of underlying Veeva Vault data architecture (Global Directory)</li>\n<li>Experience with Veeva Vault data migrations.</li>\n<li>Experience with integrating Veeva Vault with other clinical applications (e.g., EDC).</li>\n<li>Knowledge of full computer system validation lifecycle and deliverables (requirements, specifications, IQ, OQ, PQ/UAT), with Veeva-specific experience preferred.</li>\n<li>Knowledge of IT security protocols and regulatory compliance requirements (e.g., FDA 21 CFR Part 11,) including implementing secure access controls and ensuring data integrity and audit trails in clinical systems</li>\n<li>Understanding of global regulations affecting clinical trials, including ICH-GxP, FDA guidelines, and data privacy laws in various regions (e.g., GDPR).</li>\n<li>Proven ability to self-direct work, manage priorities independently, and collaborate with non-technical stakeholders to deliver functional solutions.</li>\n<li>Technical Documentation: Knowledge of creating and maintaining technical documentation, such as system manuals, standard operating procedures (SOPs), and user guides for clinical systems.</li>\n<li>Problem-Solving: The ability to quickly diagnose system issues, troubleshoot effectively, and implement solutions independently.</li>\n<li>Adaptability: Ability to adapt to new technologies and evolving regulatory requirements in the clinical space, and willingness to continuously learn and improve.</li>\n<li>Communication Skills: Strong written and verbal communication skills to work effectively with cross-functional teams, present technical information to non-technical stakeholders, and provide training and support to users.</li>\n<li>Attention to Detail: The ability to pay close attention to regulatory requirements and data accuracy, ensuring compliance and data integrity in clinical systems.</li>\n<li>Project Management and Organization: Strong organizational and time-management abilities to handle multiple projects simultaneously, ensuring timely implementation of system changes or upgrades.</li>\n"}],"salaryRange":{"min":89000,"interval":"per-year-salary","max":148000,"currency":"CAD"},"salaryDescription":"<div>Compensation for candidates will be aligned to local market benchmarks and may vary by geographic location, experience, and internal equity.&nbsp;</div>","salaryDescriptionPlain":"Compensation for candidates will be aligned to local market benchmarks and may vary by geographic location, experience, and internal equity. \n","text":"Manager, Veeva Vault Administration (Contract)","country":"CA","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>The Manager, Veeva Vault Administration is responsible for the administration and operational delivery of the Veeva Vault platform, with a focus on Vault Clinical applications (eTMF, CTMS, Study Training, Study Startup, Site Connect). This role translates strategic technology priorities into practical system solutions and oversees their implementation and ongoing management. The administrator ensures business needs are captured and aligned through planning and coordination with cross-functional teams; configures and delivers system enhancements to meet operational requirements; maintains platform integrity, compliance, and data quality; and drives user success &amp; adoption through training and responsive technical support. The role requires a high degree of self-management and initiative, with the ability to prioritize and execute tasks independently while collaborating effectively with operational teams and non-technical stakeholders.</div>","descriptionBodyPlain":"The Manager, Veeva Vault Administration is responsible for the administration and operational delivery of the Veeva Vault platform, with a focus on Vault Clinical applications (eTMF, CTMS, Study Training, Study Startup, Site Connect). This role translates strategic technology priorities into practical system solutions and oversees their implementation and ongoing management. The administrator ensures business needs are captured and aligned through planning and coordination with cross-functional teams; configures and delivers system enhancements to meet operational requirements; maintains platform integrity, compliance, and data quality; and drives user success & adoption through training and responsive technical support. The role requires a high degree of self-management and initiative, with the ability to prioritize and execute tasks independently while collaborating effectively with operational teams and non-technical stakeholders.\n","hostedUrl":"https://jobs.lever.co/alimentiv-2/6f36f72a-5c75-436b-83bd-8bf77c67e0a8","applyUrl":"https://jobs.lever.co/alimentiv-2/6f36f72a-5c75-436b-83bd-8bf77c67e0a8/apply"},{"additionalPlain":"Stay Alert to Recruitment Scams\nWe have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.\n","additional":"<div><span data-teams=\"true\"><strong>Stay Alert to Recruitment Scams</strong><br>We have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.</span></div>","categories":{"commitment":"Full-time, Permanent","department":"Medical R&D","location":"Melbourne","team":"Medical R&D Operations - Medical Monitoring","allLocations":["Melbourne","Sydney","Perth"]},"createdAt":1773250696255,"descriptionPlain":"In this role you will be providing unbiased medical guidance to clinical sites and internal and external study operations teams. You will also be providing therapeutic and compound training, medical guidance on protocol compliance, ensuring medical congruency at subject and study level and oversight of coding of medical terms. You will be responsible for supporting clinical safety, project, and data management by reviewing critical study materials at study start up stage and data listings though the study duration. You may also assist with reviewing the interim or final data sets and the writing of the final study report. Day to day you will be in regular communication with the medical team (including medical teleconferences), and interfacing with the internal cross functional teams as well as sponsor medical groups throughout the study. \n","description":"<div><span style=\"font-size: 11pt;\">In this role you will be providing unbiased medical guidance to clinical sites and internal and external study operations teams. You will also be providing therapeutic and compound training, medical guidance on protocol compliance, ensuring medical congruency at subject and study level and oversight of coding of medical terms.&nbsp;You will be responsible for supporting clinical safety, project, and data management by reviewing critical study materials at study start up stage and data listings though the study duration. You may also assist with reviewing the interim or final data sets and the writing of the final study report. Day to day you will be in regular communication with the medical team (including medical teleconferences), and interfacing with the internal cross functional teams as well as sponsor medical groups throughout the study. </span></div>","id":"09454122-2632-48bc-ae57-25e5024c3855","lists":[{"text":"Medical Oversight","content":"\n<li>Provide clarity on general protocol questions, and medical guidance for protocols as required.</li>\n<li>Serve as medical expert providing guidance on patient eligibility, and investigational product related questions.</li>\n<li>Document contacts in accordance with Alimentiv or study specific procedures.</li>\n<li>Consult with Alimentiv Medical Director(s), Sponsor Medical group and/or Safety about medical questions pertaining to the indication/compound under study.</li>\n<li>Observe and identify safety issues and other trends as appropriate.</li>\n<li>Provide consultation on the unbinding of trial participants/site staff to subject treatment allocation.</li>\n<li>Review individual, out of range laboratory values following study-specific laboratory guidelines and alert values (as appropriate).&nbsp; Review cumulative laboratory values according to the study plans.</li>\n<li>Review protocol deviation data and recommend protocol changes as appropriate.</li>\n<li>Create and follow a study-specific medical monitoring plan if applicable.</li>\n<li>Provide medical review of study level data, to identify gaps and areas requiring additional safety-related follow-up.</li>\n<li>Participate in the development, review and finalization of protocols, amendments, Clinical Study Reports, as required.</li>\n<li>Provide medical input into data collection tools, study plans (e.g., monitoring, statistical analysis plans, etc.).</li>\n<li>Provide medical input into study feasibility, site selection and site initiations as required.</li>\n<li>Attend and lead medical monitoring teleconferences at regularly scheduled intervals throughout the study, if required.</li>\n"},{"text":"Knowledge","content":"\n<li>Maintain a thorough working knowledge of protocol(s) and the current Investigator Brochure(s) with particular attention to those aspects relating to safety data involving human subjects.</li>\n"},{"text":"Training","content":"\n<li>Participates in the development and maintenance of medical educational materials.</li>\n<li>Provide internal training to Alimentiv operational teams on specific diseases, drug targets, pharmacology, protocol requirements etc., as needed to support execution of client studies or general acquisition to appropriate medical knowledge as required by the organization.</li>\n<li>Assist with the development of investigator training and meeting support materials.</li>\n<li>Attend and present at investigator meetings and CRA training meetings.</li>\n"},{"text":"Qualifications","content":"\n<li>The successful candidate must have a medical degree with a strong understanding of the drug development process, ICH and Good Clinical Practices. Typically, this person will hold about 4-6 years of related experience with substantial on-going job-related training.</li>\n<li>Strong written and verbal communication and presentation skills, enabling effective interactions with team members within Alimentiv, client company personnel and prospective sponsors.</li>\n<li>You must have the ability to exercise sound clinical judgment in addressing protocol ambiguities and unforeseen medical scenarios that arise during trial conduct. Strong analytical and critical thinking skills are essential for identifying safety signals, evaluating complex patient data, and recognizing emerging trends across study populations to ensure subject protection and data integrity.</li>\n<li>Previous experience in clinical trials is preferred especially in navigating complex medical scenarios within a CRO environment.</li>\n<li>Must be fluent in English.</li>\n"}],"text":"Medical Monitor","country":"AU","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div><span style=\"font-size: 11pt;\">In this role you will be providing unbiased medical guidance to clinical sites and internal and external study operations teams. You will also be providing therapeutic and compound training, medical guidance on protocol compliance, ensuring medical congruency at subject and study level and oversight of coding of medical terms.&nbsp;You will be responsible for supporting clinical safety, project, and data management by reviewing critical study materials at study start up stage and data listings though the study duration. You may also assist with reviewing the interim or final data sets and the writing of the final study report. Day to day you will be in regular communication with the medical team (including medical teleconferences), and interfacing with the internal cross functional teams as well as sponsor medical groups throughout the study. </span></div>","descriptionBodyPlain":"In this role you will be providing unbiased medical guidance to clinical sites and internal and external study operations teams. You will also be providing therapeutic and compound training, medical guidance on protocol compliance, ensuring medical congruency at subject and study level and oversight of coding of medical terms. You will be responsible for supporting clinical safety, project, and data management by reviewing critical study materials at study start up stage and data listings though the study duration. You may also assist with reviewing the interim or final data sets and the writing of the final study report. Day to day you will be in regular communication with the medical team (including medical teleconferences), and interfacing with the internal cross functional teams as well as sponsor medical groups throughout the study. \n","hostedUrl":"https://jobs.lever.co/alimentiv-2/09454122-2632-48bc-ae57-25e5024c3855","applyUrl":"https://jobs.lever.co/alimentiv-2/09454122-2632-48bc-ae57-25e5024c3855/apply"},{"additionalPlain":"Stay Alert to Recruitment Scams\nWe have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.\n","additional":"<div><span data-teams=\"true\"><strong>Stay Alert to Recruitment Scams</strong><br>We have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.</span></div>","categories":{"commitment":"Full-time, Permanent","department":"Medical R&D","location":"Delhi","team":"Medical R&D Operations - Medical Monitoring","allLocations":["Delhi"]},"createdAt":1773250641565,"descriptionPlain":"In this role you will be providing unbiased medical guidance to clinical sites and internal and external study operations teams. You will also be providing therapeutic and compound training, medical guidance on protocol compliance, ensuring medical congruency at subject and study level and oversight of coding of medical terms. You will be responsible for supporting clinical safety, project, and data management by reviewing critical study materials at study start up stage and data listings though the study duration. You may also assist with reviewing the interim or final data sets and the writing of the final study report. Day to day you will be in regular communication with the medical team (including medical teleconferences), and interfacing with the internal cross functional teams as well as sponsor medical groups throughout the study. \n","description":"<div><span style=\"font-size: 11pt;\">In this role you will be providing unbiased medical guidance to clinical sites and internal and external study operations teams. You will also be providing therapeutic and compound training, medical guidance on protocol compliance, ensuring medical congruency at subject and study level and oversight of coding of medical terms.&nbsp;You will be responsible for supporting clinical safety, project, and data management by reviewing critical study materials at study start up stage and data listings though the study duration. You may also assist with reviewing the interim or final data sets and the writing of the final study report. Day to day you will be in regular communication with the medical team (including medical teleconferences), and interfacing with the internal cross functional teams as well as sponsor medical groups throughout the study. </span></div>","id":"b268f375-fb0a-4f35-a2b3-1e30a53fa012","lists":[{"text":"Medical Oversight","content":"\n<li>Provide clarity on general protocol questions, and medical guidance for protocols as required.</li>\n<li>Serve as medical expert providing guidance on patient eligibility, and investigational product related questions.</li>\n<li>Document contacts in accordance with Alimentiv or study specific procedures.</li>\n<li>Consult with Alimentiv Medical Director(s), Sponsor Medical group and/or Safety about medical questions pertaining to the indication/compound under study.</li>\n<li>Observe and identify safety issues and other trends as appropriate.</li>\n<li>Provide consultation on the unbinding of trial participants/site staff to subject treatment allocation.</li>\n<li>Review individual, out of range laboratory values following study-specific laboratory guidelines and alert values (as appropriate).&nbsp; Review cumulative laboratory values according to the study plans.</li>\n<li>Review protocol deviation data and recommend protocol changes as appropriate.</li>\n<li>Create and follow a study-specific medical monitoring plan if applicable.</li>\n<li>Provide medical review of study level data, to identify gaps and areas requiring additional safety-related follow-up.</li>\n<li>Participate in the development, review and finalization of protocols, amendments, Clinical Study Reports, as required.</li>\n<li>Provide medical input into data collection tools, study plans (e.g., monitoring, statistical analysis plans, etc.).</li>\n<li>Provide medical input into study feasibility, site selection and site initiations as required.</li>\n<li>Attend and lead medical monitoring teleconferences at regularly scheduled intervals throughout the study, if required.</li>\n"},{"text":"Knowledge","content":"\n<li>Maintain a thorough working knowledge of protocol(s) and the current Investigator Brochure(s) with particular attention to those aspects relating to safety data involving human subjects.</li>\n"},{"text":"Training","content":"\n<li>Participates in the development and maintenance of medical educational materials.</li>\n<li>Provide internal training to Alimentiv operational teams on specific diseases, drug targets, pharmacology, protocol requirements etc., as needed to support execution of client studies or general acquisition to appropriate medical knowledge as required by the organization.</li>\n<li>Assist with the development of investigator training and meeting support materials.</li>\n<li>Attend and present at investigator meetings and CRA training meetings.</li>\n"},{"text":"Qualifications","content":"\n<li>The successful candidate must have a medical degree with a strong understanding of the drug development process, ICH and Good Clinical Practices. Typically, this person will hold about 4-6 years of related experience with substantial on-going job-related training.</li>\n<li>Strong written and verbal communication and presentation skills, enabling effective interactions with team members within Alimentiv, client company personnel and prospective sponsors.</li>\n<li>You must have the ability to exercise sound clinical judgment in addressing protocol ambiguities and unforeseen medical scenarios that arise during trial conduct. Strong analytical and critical thinking skills are essential for identifying safety signals, evaluating complex patient data, and recognizing emerging trends across study populations to ensure subject protection and data integrity.</li>\n<li>Previous experience in clinical trials is preferred especially in navigating complex medical scenarios within a CRO environment.</li>\n<li>Must be fluent in English.</li>\n"}],"text":"Medical Monitor","country":"IN","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div><span style=\"font-size: 11pt;\">In this role you will be providing unbiased medical guidance to clinical sites and internal and external study operations teams. You will also be providing therapeutic and compound training, medical guidance on protocol compliance, ensuring medical congruency at subject and study level and oversight of coding of medical terms.&nbsp;You will be responsible for supporting clinical safety, project, and data management by reviewing critical study materials at study start up stage and data listings though the study duration. You may also assist with reviewing the interim or final data sets and the writing of the final study report. Day to day you will be in regular communication with the medical team (including medical teleconferences), and interfacing with the internal cross functional teams as well as sponsor medical groups throughout the study. </span></div>","descriptionBodyPlain":"In this role you will be providing unbiased medical guidance to clinical sites and internal and external study operations teams. You will also be providing therapeutic and compound training, medical guidance on protocol compliance, ensuring medical congruency at subject and study level and oversight of coding of medical terms. You will be responsible for supporting clinical safety, project, and data management by reviewing critical study materials at study start up stage and data listings though the study duration. You may also assist with reviewing the interim or final data sets and the writing of the final study report. Day to day you will be in regular communication with the medical team (including medical teleconferences), and interfacing with the internal cross functional teams as well as sponsor medical groups throughout the study. \n","hostedUrl":"https://jobs.lever.co/alimentiv-2/b268f375-fb0a-4f35-a2b3-1e30a53fa012","applyUrl":"https://jobs.lever.co/alimentiv-2/b268f375-fb0a-4f35-a2b3-1e30a53fa012/apply"},{"additionalPlain":"Compensation is dependent on the unique experience, skills, and education the successful candidate brings to the role. The range above represents an estimated base salary that we would expect to compensate at, but we encourage applicants to speak with the member of the TA team if contacted for an initial phone screen should your expectations differ from those listed above.\n","additional":"<div>Compensation is dependent on the unique experience, skills, and education the successful candidate brings to the role. The range above represents an estimated base salary that we would expect to compensate at, but we encourage applicants to speak with the member of the TA team if contacted for an initial phone screen should your expectations differ from those listed above.</div>","categories":{"commitment":"Full-time, Permanent","department":"AcelaBio","location":"San Diego, California","team":"AcelaBio","allLocations":["San Diego, California"]},"createdAt":1769125127574,"descriptionPlain":"About AcelaBio\nAcelaBio is a CAP- and CLIA-accredited specialty histopathology laboratory based in San Diego, CA. We deliver anatomic histopathology, immunostaining, digital image analysis, spatial transcriptomics, and biomarker endpoints to pharmaceutical and biotechnology sponsors. Our team is scientifically driven, client-focused, and committed to advancing translational research through rigorous, reproducible methods.\nAbout the opportunity\nThis is a high-impact, technically hands-on role at the intersection of immunostaining assay development, quantitative image analysis, and client science. You will build and optimize IHC, multiplex IF, and ISH assays from the ground up, develop and maintain AI-assisted image analysis pipelines, and serve as a scientific lead for sponsor studies across preclinical and clinical programs.\nYou will work directly with pathologists, laboratory technicians, project operations, and business development teams, and will be a visible scientific partner to our pharmaceutical and biotechnology clients. If you are someone who thrives on solving complex assay challenges, values scientific rigor, and enjoys translating data into clear, actionable insights for sponsors, this role is built for you.\nRole Logistics: On-site, San Diego (required). Travel expectations ~ 10% \n","description":"<div><strong><span style=\"font-size: 16px;\">About AcelaBio</span></strong></div>\n<div>\n<p style=\"text-align: left;\">AcelaBio is a CAP- and CLIA-accredited specialty histopathology laboratory based in San Diego, CA.&nbsp;We deliver anatomic histopathology, immunostaining, digital image analysis, spatial transcriptomics,&nbsp;and biomarker endpoints to pharmaceutical and biotechnology sponsors. Our team is scientifically&nbsp;driven, client-focused, and committed to advancing translational research through rigorous,&nbsp;reproducible methods.</p>\n</div>\n<div><strong><span style=\"font-size: 16px;\">About the opportunity</span></strong></div>\n<div>\n<p>This is a high-impact, technically hands-on role at the intersection of immunostaining assay&nbsp;development, quantitative image analysis, and client science. You will build and optimize IHC,&nbsp;multiplex IF, and ISH assays from the ground up, develop and maintain AI-assisted image analysis&nbsp;pipelines, and serve as a scientific lead for sponsor studies across preclinical and clinical programs.</p>\n<p>You will work directly with pathologists, laboratory technicians, project operations, and business&nbsp;development teams, and will be a visible scientific partner to our pharmaceutical and biotechnology&nbsp;clients. If you are someone who thrives on solving complex assay challenges, values scientific rigor,&nbsp;and enjoys translating data into clear, actionable insights for sponsors, this role is built for you.</p>\n<p><strong>Role Logistics:</strong> On-site, San Diego (required). Travel expectations ~ 10%&nbsp;</p>\n</div>","id":"c64616a2-9baa-4a03-a349-702e7f80da12","lists":[{"text":"Responsibilities","content":"\n<li><strong>What you'll be doing: </strong></li>\n\n<div>\n<div><strong>Assay Development, Image Analysis (Core Focus):</strong></div>\n\n<li>Design, develop, optimize, and validate immunostaining assays including single-plex IHC,&nbsp;multiplex immunofluorescence (mIF), in situ hybridization (ISH), and spatial biology platforms.</li>\n<li>Define analytical endpoints, scoring strategies, and QC metrics aligned with assay performance requirements.</li>\n<li>Develop, validate, and maintain image analysis pipelines using platforms such as Visiopharm,&nbsp;HALO, or equivalent software.</li>\n<li>Build and implement AI/machine learning algorithms for tissue segmentation, cell phenotyping,&nbsp;and biomarker quantification.</li>\n<li>Ensure traceability, reproducibility, and thorough documentation of all analysis workflows.</li>\n<li>Contribute to assay validation documentation, analytical reports, and regulatory-aligned&nbsp;deliverables.</li>\n<li>Partner with histotechnicians to support hands-on assay troubleshooting and knowledge&nbsp;transfer</li>\n\n<strong>Scientific Leadership &amp; Client Engagement;</strong></div>\n\n<li>Serve as a scientific interface for sponsors, participating in protocol reviews, study design discussions, and data review meetings.</li>\n<li>Provide expert guidance on biomarker study design incorporating omics and non-omics endpoints.</li>\n<li>Prepare and review project plans, analysis plans, study reports, abstracts, and technical manuscripts.&nbsp;</li>\n<li>Deliver clear, scientifically rigorous data visualizations, analyses, and summaries tailored to sponsor audiences&nbsp;</li>\n\n<div>&nbsp;</div>\n<div><strong>Business Development and Innovation:</strong></div>\n\n<li>Support RFP responses, project pricing, protocol review, and bid defense activities.</li>\n<li>Contribute to the development of sales, marketing, and promotional scientific content.</li>\n<li>Drive continuous improvement of our computational pathology, spatial biology, and translational&nbsp;research service offerings.</li>\n<li>Participate in capability development and functionality reviews to expand the AcelaBio service&nbsp;portfolio.</li>\n"},{"text":"Qualifications","content":"\n<li>\n<p><strong>Education and Experience:</strong></p>\n\n</li><li>Graduate degree (M.Sc. or Ph.D.) in a relevant scientific discipline (pathology, cell biology,&nbsp;molecular biology, biomedical engineering, or related field).</li>\n<li>7 or more years of hands-on experience in IHC/IF assay development and image analysis in a&nbsp;CRO, biopharma, or regulated research environment.</li>\n<li>Demonstrated experience building image analysis algorithms or pipelines in platforms such as&nbsp;Visiopharm, HALO, or similar.</li>\n<li>Exposure to spatial biology platforms (e.g., 10x Visium, Xenium, Akoya PhenoCycler) is a strong&nbsp;asset.</li>\n\n\n\n\n<li><strong>Technical Skills &amp; Competencies</strong>:\n\n</li><li>Deep practical knowledge of chromogenic IHC and multiplex immunofluorescence, including&nbsp;antibody selection, panel design, optimization, and troubleshooting.</li>\n<li>Proficiency in digital pathology image analysis and quantitative biomarker readout strategies.</li>\n<li>Familiarity with AI/ML approaches for histopathology applications.</li>\n<li>Understanding of regulatory and GxP expectations for assay validation documentation.</li>\n<li>Scientific rigor and meticulous attention to detail.</li>\n<li>Ability to communicate complex scientific concepts clearly to both technical and non-technical&nbsp;stakeholders.</li>\n<li>Strong written and oral English communication skills; comfortable presenting at client meetings&nbsp;and scientific forums.</li>\n<li>Ability to manage multiple projects in a fast-paced, client-driven environment.</li>\n<li>Collaborative mindset with the ability to work across laboratory, scientific, and operational&nbsp;functions.</li>\n\n\n"}],"salaryRange":{"min":150000,"max":200000,"currency":"USD","interval":"per-year-salary"},"salaryDescription":"<div>+ bonus</div>\n<div>&nbsp;</div>\n<div>&nbsp;</div>\n<div><span data-teams=\"true\"><strong>Stay Alert to Recruitment Scams</strong><br>We have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.</span></div>","salaryDescriptionPlain":"+ bonus\n \n \nStay Alert to Recruitment Scams\nWe have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.\n","text":"Scientist, Computational & Digital Pathology (AcelaBio)","country":"US","workplaceType":"hybrid","opening":"","openingPlain":"","descriptionBody":"<div><strong><span style=\"font-size: 16px;\">About AcelaBio</span></strong></div>\n<div>\n<p style=\"text-align: left;\">AcelaBio is a CAP- and CLIA-accredited specialty histopathology laboratory based in San Diego, CA.&nbsp;We deliver anatomic histopathology, immunostaining, digital image analysis, spatial transcriptomics,&nbsp;and biomarker endpoints to pharmaceutical and biotechnology sponsors. Our team is scientifically&nbsp;driven, client-focused, and committed to advancing translational research through rigorous,&nbsp;reproducible methods.</p>\n</div>\n<div><strong><span style=\"font-size: 16px;\">About the opportunity</span></strong></div>\n<div>\n<p>This is a high-impact, technically hands-on role at the intersection of immunostaining assay&nbsp;development, quantitative image analysis, and client science. You will build and optimize IHC,&nbsp;multiplex IF, and ISH assays from the ground up, develop and maintain AI-assisted image analysis&nbsp;pipelines, and serve as a scientific lead for sponsor studies across preclinical and clinical programs.</p>\n<p>You will work directly with pathologists, laboratory technicians, project operations, and business&nbsp;development teams, and will be a visible scientific partner to our pharmaceutical and biotechnology&nbsp;clients. If you are someone who thrives on solving complex assay challenges, values scientific rigor,&nbsp;and enjoys translating data into clear, actionable insights for sponsors, this role is built for you.</p>\n<p><strong>Role Logistics:</strong> On-site, San Diego (required). Travel expectations ~ 10%&nbsp;</p>\n</div>","descriptionBodyPlain":"About AcelaBio\nAcelaBio is a CAP- and CLIA-accredited specialty histopathology laboratory based in San Diego, CA. We deliver anatomic histopathology, immunostaining, digital image analysis, spatial transcriptomics, and biomarker endpoints to pharmaceutical and biotechnology sponsors. Our team is scientifically driven, client-focused, and committed to advancing translational research through rigorous, reproducible methods.\nAbout the opportunity\nThis is a high-impact, technically hands-on role at the intersection of immunostaining assay development, quantitative image analysis, and client science. You will build and optimize IHC, multiplex IF, and ISH assays from the ground up, develop and maintain AI-assisted image analysis pipelines, and serve as a scientific lead for sponsor studies across preclinical and clinical programs.\nYou will work directly with pathologists, laboratory technicians, project operations, and business development teams, and will be a visible scientific partner to our pharmaceutical and biotechnology clients. If you are someone who thrives on solving complex assay challenges, values scientific rigor, and enjoys translating data into clear, actionable insights for sponsors, this role is built for you.\nRole Logistics: On-site, San Diego (required). Travel expectations ~ 10% \n","hostedUrl":"https://jobs.lever.co/alimentiv-2/c64616a2-9baa-4a03-a349-702e7f80da12","applyUrl":"https://jobs.lever.co/alimentiv-2/c64616a2-9baa-4a03-a349-702e7f80da12/apply"},{"additionalPlain":"Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle. Requests can be directed to recruitment@alimentiv.com\n \nPHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.\n \n","additional":"<div><em>Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle. Requests can be directed to recruitment@alimentiv.com</em></div>\n<div>&nbsp;</div>\n<div><span style=\"font-size: 10pt;\">PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@</span><a rel=\"noopener noreferrer\" href=\"http://alimentiv.com\" style=\"font-size: 10pt;\" class=\"postings-link\">alimentiv.com</a><span style=\"font-size: 10pt;\">”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.</span></div>\n<div>&nbsp;</div>","categories":{"commitment":"Full-time, Permanent","department":"Clinical Services","location":"Boston, Massachusetts","team":"Clinical Study Delivery - Monitoring & Site Management","allLocations":["Boston, Massachusetts","New York, New York","Newark, New Jersey","Philadelphia, Pennsylvania","Jacksonville, Florida","Washington, DC","Raleigh-Durham, North Carolina","Baltimore, Maryland"]},"createdAt":1771527318377,"descriptionPlain":"Responsible for the clinical operations of a project within a defined regional/global level.  Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations.  The COL acts as a primary liaison between the CRAs and the clinical project team.  Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.  The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.\n","description":"<div>Responsible for the clinical operations of a project within a defined regional/global level.&nbsp; Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations.&nbsp; The COL acts as a primary liaison between the CRAs and the clinical project team.&nbsp; Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.&nbsp; The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.</div>","id":"205ad099-7618-43bf-a40b-25bcfc685aa1","lists":[{"text":"Project Oversight","content":"\n<li>Overall oversight of (a group of) regional CRAs to ensure (site) compliance with study protocol, study plans, ICH-GCP, local regulations and study timelines.</li>\n<li>Monitoring support visits (Co-monitoring), per project requirements, to aid the site/CRA in the satisfactory performance and compliance with standards mentioned above.</li>\n<li>May support clinical project team by providing oversight of study deliverables related to other departments (e.g. Data Management, TMF Operations, etc.)</li>\n<li>Oversee regional startup and feasibility activities.</li>\n<li>Assist in vendor management activities as required per project.</li>\n<li>Perform review of visit reports for quality, compliance and appropriate site management.</li>\n<li>Assure compliance with high quality and timely project deliverables according to the project requirements and the monitoring plan.</li>\n<li>Proactive management of site and country performance (recruitment, data collection, document collection, TMF review etc.) and inform clinical project team on progress.</li>\n<li>Contribute to financial project management processes as applicable.&nbsp; May include but may not be limited to input on revenue recognition, site payments, and site pass-through expense review.</li>\n<li>May be required to manage/oversee investigator sites including CRA responsibilities, on a temporary or permanent basis.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;</li>\n"},{"text":"Project Liaison","content":"\n<li>Conduct regular global CRA calls with the monitoring and site management team, as well as individual/country CRA calls&nbsp;</li>\n<li>Attend meetings with Study Sponsor to provide status updates on country and site progress</li>\n<li>Provide operational support and guidance to the monitoring team throughout project.</li>\n<li>Provide project training/mentoring to regional CRAs on study procedures, clinical plans and guidelines, and timelines for the study. Ensures study specific training requirements are completed and documented.</li>\n<li>First point of contact for regional CRAs for study-specific questions and issues. Escalates to PM and other functions as appropriate.</li>\n<li>Support line managers by providing status updates on utilization and performance of CRAs.&nbsp;</li>\n<li>Liaise with line manager for assigning sites to CRAs following line manager allocation of a CRA resource to the project.&nbsp;</li>\n<li>Conduct CRA Assessment visits per departmental requirements to assess the performance of the CRA against their monitoring responsibilities.</li>\n"},{"text":"Study Documents and Plans","content":"\n<li>Develop training materials and study tools for sites and CRAs, including monitoring plans.</li>\n<li>Develop and implement enrolment and recruitment strategies together with clinical project team.</li>\n<li>Develop presentation materials for and presents at Sponsor Kickoff meetings, Investigator meetings and Sponsor Calls (as needed), and prepares presentations for Site Qualification Visits and Site Initiation Visits.</li>\n\n<div>&nbsp;</div>"},{"text":"Qualifications ","content":"\n<li>College diploma/degree AND 7-9 years related experience +continuous training and knowledge/skills upgrading</li>\n\n<div>OR</div>\n\n<li>Undergraduate university degree (Bachelors or Honors Bachelors) AND 4-6 years' experience + substantial on-going job-related training</li>\n"},{"text":"Other","content":"\n<li>Health Sciences, Life Sciences or Nursing specialty preferred, or SoCRA and/or ACRP Certification/Designation.</li>\n<li>Should have a minimum of 3 years CRA experience, have strong experience with EDC systems, be proficient with MS Office, have strong written and verbal communication skills and highly effective interpersonal and organizational skills.</li>\n<li>Demonstrate the following attributes: proactive, detail oriented, task-driven and highly organized.</li>\n<li>Demonstrate the critical elements of GCPs and local regulations as they relate to clinical monitoring, IRB/EC and Investigator responsibilities.</li>\n<li>Demonstrated ability in report writing and strong ability to critically understand clinical research documents.</li>\n<li>Ability to handle multiple tasks to meet deadlines in a dynamic environment.&nbsp;</li>\n\n<div>&nbsp;</div>"},{"text":"Working Conditions","content":"\n<li>Home-based</li>\n"}],"salaryRange":{"currency":"USD","interval":"per-year-salary","min":86000,"max":143000},"salaryDescription":"<div>+ Bonus</div>","salaryDescriptionPlain":"+ Bonus\n","text":"Sr. Clinical Operations Lead","country":"US","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>Responsible for the clinical operations of a project within a defined regional/global level.&nbsp; Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations.&nbsp; The COL acts as a primary liaison between the CRAs and the clinical project team.&nbsp; Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.&nbsp; The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.</div>","descriptionBodyPlain":"Responsible for the clinical operations of a project within a defined regional/global level.  Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations.  The COL acts as a primary liaison between the CRAs and the clinical project team.  Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.  The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.\n","hostedUrl":"https://jobs.lever.co/alimentiv-2/205ad099-7618-43bf-a40b-25bcfc685aa1","applyUrl":"https://jobs.lever.co/alimentiv-2/205ad099-7618-43bf-a40b-25bcfc685aa1/apply"},{"additionalPlain":"Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle. Requests can be directed to recruitment@alimentiv.com\n \nPHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.\n \n","additional":"<div><em>Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle. Requests can be directed to recruitment@alimentiv.com</em></div>\n<div>&nbsp;</div>\n<div><span style=\"font-size: 10pt;\">PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@</span><a rel=\"noopener noreferrer\" href=\"http://alimentiv.com\" style=\"font-size: 10pt;\" class=\"postings-link\">alimentiv.com</a><span style=\"font-size: 10pt;\">”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.</span></div>\n<div>&nbsp;</div>","categories":{"commitment":"Full-time, Permanent","department":"Clinical Services","location":"Toronto, Ontario","team":"Clinical Study Delivery - Monitoring & Site Management","allLocations":["Toronto, Ontario","London, Ontario"]},"createdAt":1780691624956,"descriptionPlain":"Responsible for the clinical operations of a project within a defined regional/global level.  Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations.  The COL acts as a primary liaison between the CRAs and the clinical project team.  Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.  The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.\n","description":"<div>Responsible for the clinical operations of a project within a defined regional/global level.&nbsp; Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations.&nbsp; The COL acts as a primary liaison between the CRAs and the clinical project team.&nbsp; Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.&nbsp; The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.</div>","id":"3529f5db-5472-4cf0-8ee7-41829db39107","lists":[{"text":"Project Oversight","content":"\n<li>Overall oversight of (a group of) regional CRAs to ensure (site) compliance with study protocol, study plans, ICH-GCP, local regulations and study timelines.</li>\n<li>Monitoring support visits (Co-monitoring), per project requirements, to aid the site/CRA in the satisfactory performance and compliance with standards mentioned above.</li>\n<li>May support clinical project team by providing oversight of study deliverables related to other departments (e.g. Data Management, TMF Operations, etc.)</li>\n<li>Oversee regional startup and feasibility activities.</li>\n<li>Assist in vendor management activities as required per project.</li>\n<li>Perform review of visit reports for quality, compliance and appropriate site management.</li>\n<li>Assure compliance with high quality and timely project deliverables according to the project requirements and the monitoring plan.</li>\n<li>Proactive management of site and country performance (recruitment, data collection, document collection, TMF review etc.) and inform clinical project team on progress.</li>\n<li>Contribute to financial project management processes as applicable.&nbsp; May include but may not be limited to input on revenue recognition, site payments, and site pass-through expense review.</li>\n<li>May be required to manage/oversee investigator sites including CRA responsibilities, on a temporary or permanent basis.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;</li>\n"},{"text":"Project Liaison","content":"\n<li>Conduct regular global CRA calls with the monitoring and site management team, as well as individual/country CRA calls&nbsp;</li>\n<li>Attend meetings with Study Sponsor to provide status updates on country and site progress</li>\n<li>Provide operational support and guidance to the monitoring team throughout project.</li>\n<li>Provide project training/mentoring to regional CRAs on study procedures, clinical plans and guidelines, and timelines for the study. Ensures study specific training requirements are completed and documented.</li>\n<li>First point of contact for regional CRAs for study-specific questions and issues. Escalates to PM and other functions as appropriate.</li>\n<li>Support line managers by providing status updates on utilization and performance of CRAs.&nbsp;</li>\n<li>Liaise with line manager for assigning sites to CRAs following line manager allocation of a CRA resource to the project.&nbsp;</li>\n<li>Conduct CRA Assessment visits per departmental requirements to assess the performance of the CRA against their monitoring responsibilities.</li>\n"},{"text":"Study Documents and Plans","content":"\n<li>Develop training materials and study tools for sites and CRAs, including monitoring plans.</li>\n<li>Develop and implement enrolment and recruitment strategies together with clinical project team.</li>\n<li>Develop presentation materials for and presents at Sponsor Kickoff meetings, Investigator meetings and Sponsor Calls (as needed), and prepares presentations for Site Qualification Visits and Site Initiation Visits.</li>\n\n<div>&nbsp;</div>"},{"text":"Qualifications ","content":"\n<li>College diploma/degree AND 7-9 years related experience +continuous training and knowledge/skills upgrading</li>\n\n<div>OR</div>\n\n<li>Undergraduate university degree (Bachelors or Honors Bachelors) AND 4-6 years' experience + substantial on-going job-related training</li>\n"},{"text":"Other","content":"\n<li>Health Sciences, Life Sciences or Nursing specialty preferred, or SoCRA and/or ACRP Certification/Designation.</li>\n<li>Should have a minimum of 3 years CRA experience, have strong experience with EDC systems, be proficient with MS Office, have strong written and verbal communication skills and highly effective interpersonal and organizational skills.</li>\n<li>Demonstrate the following attributes: proactive, detail oriented, task-driven and highly organized.</li>\n<li>Demonstrate the critical elements of GCPs and local regulations as they relate to clinical monitoring, IRB/EC and Investigator responsibilities.</li>\n<li>Demonstrated ability in report writing and strong ability to critically understand clinical research documents.</li>\n<li>Ability to handle multiple tasks to meet deadlines in a dynamic environment.&nbsp;</li>\n\n<div>&nbsp;</div>"},{"text":"Working Conditions","content":"\n<li>Home-based</li>\n"}],"salaryRange":{"currency":"CAD","interval":"per-year-salary","min":78000,"max":130000},"salaryDescription":"<div>+ Bonus</div>","salaryDescriptionPlain":"+ Bonus\n","text":"Sr. Clinical Operations Lead","country":"CA","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>Responsible for the clinical operations of a project within a defined regional/global level.&nbsp; Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations.&nbsp; The COL acts as a primary liaison between the CRAs and the clinical project team.&nbsp; Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.&nbsp; The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.</div>","descriptionBodyPlain":"Responsible for the clinical operations of a project within a defined regional/global level.  Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations.  The COL acts as a primary liaison between the CRAs and the clinical project team.  Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.  The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.\n","hostedUrl":"https://jobs.lever.co/alimentiv-2/3529f5db-5472-4cf0-8ee7-41829db39107","applyUrl":"https://jobs.lever.co/alimentiv-2/3529f5db-5472-4cf0-8ee7-41829db39107/apply"},{"additionalPlain":"Stay Alert to Recruitment Scams\nWe have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.\n","additional":"<div><span data-teams=\"true\"><strong>Stay Alert to Recruitment Scams</strong><br>We have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.</span></div>","categories":{"commitment":"Full-time, Permanent","department":"Clinical Services","location":"Chișinău","team":"Clinical Study Delivery - Monitoring & Site Management","allLocations":["Chișinău"]},"createdAt":1778000747812,"descriptionPlain":"Manage, deliver and/or perform full clinical site monitoring services for one or more projects, which may include multiple services, be complex in nature and/or run on a multinational scale.  In-house based position, responsible for the design and oversight of project monitoring services including training, site/patient recruitment, site data/document management, monitoring project site budgets and regulatory filings that aligns with SOPs, study guidelines and GCP best practices.  In the function of Lead CRA, will act as primary liaison between CRAs and project team and may be required to participate in the development of project plans, protocols, CRFs, communications or other monitoring forms, documents and tools. Represents the corporation by maintaining collaborative relationships with stakeholders.\n \n(Fluency in English Required, Romanian translation follows).\n","description":"<div><span style=\"font-size: 15px;\">Manage, deliver and/or perform full clinical site monitoring services for one or more projects, which may include multiple services, be complex in nature and/or run on a multinational scale.&nbsp; In-house based position, responsible for the design and oversight of project monitoring services including training, site/patient recruitment, site data/document management, monitoring project site budgets and regulatory filings that aligns with SOPs, study guidelines and GCP best practices.&nbsp; In the function of Lead CRA, will act as primary liaison between CRAs and project team and may be required to participate in the development of project plans, protocols, CRFs, communications or other monitoring forms, documents and tools. Represents the corporation by maintaining collaborative relationships with stakeholders.</span></div>\n<div>&nbsp;</div>\n<div><span style=\"font-size: 15px;\">(Fluency in English Required, Romanian translation follows).</span></div>","id":"88e8d351-23ec-42a2-8c44-3b0ef7621332","lists":[{"text":"Monitoring - Subject Expert ","content":"\n<li>Act as subject matter expert, mentor, coach and/or provide performance feedback to manager for peers.</li>\n<li>Assist with selection, hiring, training, and supervision of CRAs as needed. Perform co-monitoring and training visits with CRAs.&nbsp;</li>\n<li>When required, act as the first escalation point for the resolution of site/patient issues or to address Sponsor concerns.</li>\n<li>May represent Director, Monitoring and Site Management or Manager, Clinical Site Management in BD initiatives with a site monitoring focus.</li>\n"},{"text":"Project Monitoring Lead","content":"\n<li>May be assigned Lead CRA role and manage monitoring services for a group of projects and/or CRAs on large/complex project(s) including directing/guiding day to day activities and review/approval of monitoring reports.</li>\n<li>Function as liaison between CRAs and other functional teams, escalating concerns and issues to management as needed.</li>\n<li>Participate and/or present at study team, kickoff and investigator meetings and act as primary contact to sponsors for all monitoring related issues.</li>\n"},{"text":"Site Recruitment and Setup ","content":"\n<li>Identify and recruit site investigators, coordinate the movement and delivery of trial materials, samples, tests and forms, including investigational product, protocols, SOPs, CRFs, project documents, forms and support tools.</li>\n<li>Ensure SOPs in place to optimize patient recruitment providing guidance to site teams of inclusion/exclusion criteria.</li>\n"},{"text":"Investigational Site Monitoring ","content":"\n<li>Primary clinical site contact.</li>\n<li>May act as primary contact for any questions or issues that arise from investigational sites.</li>\n<li>Oversee overall integrity of the study to promote positive working relationships with the site and staff.</li>\n<li>Facilitate and support site staff with access to study systems and ensure sites are compliant with project specific training requirements.</li>\n<li>Ensure all site related issues are followed until resolution.</li>\n<li>Coordinate delivery of clinical sites communications, collaborating with project teams, to ensure investigational sites are provided accurate ongoing data, updates, information and feedback on project/regulatory guidelines and objectives throughout the project lifecycle.</li>\n"},{"text":"Qualifications ","content":"\n<li>The successful candidate will possess a minimum of a college diploma/degree and 4-6 years of related experience.</li>\n<li>Self-motivation with strong communication skills and a commitment to achieving positive results.&nbsp;</li>\n<li>Strong attention to detail and keenness to understand the importance of building collaborative relationships to achieve results.&nbsp;</li>\n<li>Critical thinking abilities</li>\n<li>Ability to regularly travel to sites.</li>\n"},{"text":"Working Conditions ","content":"\n<li>Home-based</li>\n<li>Regular travel is required</li>\n"},{"text":"","content":"<div>\n<div><strong data-olk-copy-source=\"MessageBody\">Asociat Senior de Cercetare Clinică (România)</strong>&nbsp;</div>\n<div>București | Servicii Clinice – Livrare Studii Clinice - Monitorizare și Management de Sit / Full-time, Permanent / Remote</div>\n<div>&nbsp;</div>\n<div>Gestionați, livrați și/sau efectuați servicii complete de monitorizare a siturilor clinice pentru unul sau mai multe proiecte, care pot include servicii multiple, pot fi complexe prin natura lor și/sau se desfășoară la scară multinațională. Poziție bazată intern, responsabilă de proiectarea și supravegherea serviciilor de monitorizare a proiectelor, inclusiv formarea, recrutarea siturilor/pacienților, gestionarea datelor/documentelor de sit, monitorizarea bugetelor de sit ale proiectelor și dosarele de reglementare, în conformitate cu SOPs, ghidurile studiului și bunele practici GCP. În funcția de CRA Principal, va acționa ca legătură principală între CRAs și echipa de proiect și poate fi solicitat să participe la elaborarea planurilor de proiect, protocoalelor, CRF-urilor, comunicărilor sau altor formulare, documente și instrumente de monitorizare. Reprezintă compania prin menținerea unor relații de colaborare cu părțile interesate.</div>\n<hr>\n<div><strong>Monitorizare - Expert în Domeniu</strong></div>\n\n<li>Acționați ca expert în domeniu, mentor, coach și/sau furnizați feedback de performanță managerului pentru colegi.</li>\n<li>Asistați la selecția, angajarea, formarea și supervizarea CRAs după caz. Efectuați vizite de co-monitorizare și formare cu CRAs.</li>\n<li>Când este necesar, acționați ca prim punct de escaladare pentru rezolvarea problemelor de sit/pacient sau pentru a aborda îngrijorările Sponsorului.</li>\n<li>Poate reprezenta Directorul, Monitorizare și Management de Sit sau Managerul, Management Sit Clinic în inițiative BD cu accent pe monitorizarea sitului.</li>\n\n<hr>\n<div><strong>Responsabil Principal de Monitorizare a Proiectului</strong></div>\n\n<li>Poate fi desemnat în rolul de CRA Principal și gestionează serviciile de monitorizare pentru un grup de proiecte și/sau CRAs pe proiecte mari/complexe, inclusiv direcționarea/ghidarea activităților zilnice și revizuirea/aprobarea rapoartelor de monitorizare.</li>\n<li>Funcționează ca legătură între CRAs și alte echipe funcționale, escaladând îngrijorările și problemele către management după caz.</li>\n<li>Participați și/sau prezentați la întâlnirile echipei de studiu, ședințele de lansare și întâlnirile investigatorilor și acționați ca principal contact al sponsorilor pentru toate problemele legate de monitorizare.</li>\n\n<hr>\n<div><strong>Recrutarea și Configurarea Sitului</strong></div>\n\n<li>Identificați și recrutați investigatori de sit, coordonați mișcarea și livrarea materialelor de studiu, probelor, testelor și formularelor, inclusiv produsul investigațional, protocoalele, SOPs, CRF-urile, documentele de proiect, formularele și instrumentele de suport.</li>\n<li>Asigurați-vă că SOPs sunt în vigoare pentru a optimiza recrutarea pacienților, oferind îndrumare echipelor de sit cu privire la criteriile de includere/excludere.</li>\n\n<hr>\n<div><strong>Monitorizarea Sitului de Investigație</strong></div>\n\n<li>Contact principal al sitului clinic.</li>\n<li>Poate acționa ca principal contact pentru orice întrebări sau probleme care apar de la siturile de investigație.</li>\n<li>Supravegheați integritatea generală a studiului pentru a promova relații de lucru pozitive cu situl și personalul.</li>\n<li>Facilitați și sprijiniți personalul de sit cu accesul la sistemele studiului și asigurați-vă că siturile respectă cerințele de formare specifice proiectului.</li>\n<li>Asigurați-vă că toate problemele legate de sit sunt urmărite până la rezolvare.</li>\n<li>Coordonați livrarea comunicărilor siturilor clinice, colaborând cu echipele de proiect, pentru a vă asigura că siturile de investigație primesc date, actualizări, informații și feedback precise și continue privind ghidurile și obiectivele proiectului/reglementare pe parcursul ciclului de viață al proiectului.</li>\n\n<hr>\n<div><strong>Calificări</strong></div>\n\n<li>Candidatul de succes va poseda cel puțin o diplomă de colegiu/licență și 4-6 ani de experiență relevantă.</li>\n<li>Candidatul de succes trebuie să demonstreze următoarele competențe: automotivare cu abilități puternice de comunicare și angajament față de obținerea de rezultate pozitive.</li>\n<li>Atenție deosebită la detalii și dorința de a înțelege importanța construirii unor relații de colaborare pentru atingerea rezultatelor.</li>\n<li>Capacitatea de a se angaja în învățare continuă și auto-dezvoltare.</li>\n<li>Capacitatea de a promova continuu munca în echipă.</li>\n\n<hr>\n<div><strong>Condiții de Muncă</strong></div>\n\n<li>Lucru de acasă</li>\n<li>Călătorii regulate</li>\n<li>200.000 - 250.000 lei pe an</li>\n\n<div><strong>Bonus la angajare:</strong>&nbsp;Acest rol include un bonus unic la angajare în recunoașterea rolului cheie în expansiunea noastră inițială în această zonă. (~15.225 RON)</div>\n<div>&nbsp;</div>\n<div><strong>Suplimentar:</strong></div>\n\n<li>Bonus anual (Program de Stimulente pe Termen Scurt) țintă = 8% din salariul anual</li>\n<li>O indemnizație lunară de 400 RON (calculată proporțional în funcție de orele de muncă), plătită odată cu salariul regulat/adăugată la venitul impozabil. Aceasta este destinată să compenseze utilizarea în scop profesional a costurilor de comunicare ale angajatului (internet, VoIP, linie fixă etc.)</li>\n<li>Indemnizație lunară pentru telefon mobil (50 RON)</li>\n<li>O rambursare unică de cheltuieli de până la 500,00 (monedă locală) pentru achiziționarea altor articole de birou, cum ar fi un scaner/imprimantă, un monitor suplimentar, mobilier de birou și consumabile etc.</li>\n<li>Rambursarea kilometrajului pentru călătorii</li>\n\n<hr>\n<div>Vă reamintesc că acest anunț conține informații despre compensații și beneficii specifice rolului -- asigurați-vă că datele sunt revizuite de echipa relevantă înainte de publicare, în conformitate cu politicile Alimentiv.</div>\n<div>&nbsp;</div>\n</div>"}],"text":"Sr. Clinical Research Associate","country":"MD","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div><span style=\"font-size: 15px;\">Manage, deliver and/or perform full clinical site monitoring services for one or more projects, which may include multiple services, be complex in nature and/or run on a multinational scale.&nbsp; In-house based position, responsible for the design and oversight of project monitoring services including training, site/patient recruitment, site data/document management, monitoring project site budgets and regulatory filings that aligns with SOPs, study guidelines and GCP best practices.&nbsp; In the function of Lead CRA, will act as primary liaison between CRAs and project team and may be required to participate in the development of project plans, protocols, CRFs, communications or other monitoring forms, documents and tools. Represents the corporation by maintaining collaborative relationships with stakeholders.</span></div>\n<div>&nbsp;</div>\n<div><span style=\"font-size: 15px;\">(Fluency in English Required, Romanian translation follows).</span></div>","descriptionBodyPlain":"Manage, deliver and/or perform full clinical site monitoring services for one or more projects, which may include multiple services, be complex in nature and/or run on a multinational scale.  In-house based position, responsible for the design and oversight of project monitoring services including training, site/patient recruitment, site data/document management, monitoring project site budgets and regulatory filings that aligns with SOPs, study guidelines and GCP best practices.  In the function of Lead CRA, will act as primary liaison between CRAs and project team and may be required to participate in the development of project plans, protocols, CRFs, communications or other monitoring forms, documents and tools. Represents the corporation by maintaining collaborative relationships with stakeholders.\n \n(Fluency in English Required, Romanian translation follows).\n","hostedUrl":"https://jobs.lever.co/alimentiv-2/88e8d351-23ec-42a2-8c44-3b0ef7621332","applyUrl":"https://jobs.lever.co/alimentiv-2/88e8d351-23ec-42a2-8c44-3b0ef7621332/apply"},{"additionalPlain":"PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.\n","additional":"<div><span style=\"font-size: 10pt;\">PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@</span><a rel=\"noopener noreferrer\" href=\"http://alimentiv.com\" style=\"font-size: 10pt;\" class=\"postings-link\">alimentiv.com</a><span style=\"font-size: 10pt;\">”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.</span></div>","categories":{"commitment":"Full-time, Permanent","department":"Clinical Services","location":"Queensland","team":"Clinical Study Delivery - Monitoring & Site Management","allLocations":["Queensland"]},"createdAt":1780768907029,"descriptionPlain":"Manage, deliver and/or perform full clinical site monitoring services for one or more projects, which may include multiple services, be complex in nature and/or run on a multinational scale.  In-house based position, responsible for the design and oversight of project monitoring services including training, site/patient recruitment, site data/document management, monitoring project site budgets and regulatory filings that aligns with SOPs, study guidelines and GCP best practices.  In the function of Lead CRA, will act as primary liaison between CRAs and project team and may be required to participate in the development of project plans, protocols, CRFs, communications or other monitoring forms, documents and tools. Represents the corporation by maintaining collaborative relationships with stakeholders.\n","description":"<div><span style=\"font-size: 15px;\">Manage, deliver and/or perform full clinical site monitoring services for one or more projects, which may include multiple services, be complex in nature and/or run on a multinational scale.&nbsp; In-house based position, responsible for the design and oversight of project monitoring services including training, site/patient recruitment, site data/document management, monitoring project site budgets and regulatory filings that aligns with SOPs, study guidelines and GCP best practices.&nbsp; In the function of Lead CRA, will act as primary liaison between CRAs and project team and may be required to participate in the development of project plans, protocols, CRFs, communications or other monitoring forms, documents and tools. Represents the corporation by maintaining collaborative relationships with stakeholders.</span></div>","id":"45952406-28db-4d77-a961-d06e32c5dd53","lists":[{"text":"Monitoring-Subject Expert","content":"\n<li>Act as subject matter expert, mentor, coach and/or provide performance feedback to manager for peers.</li>\n<li>Assist with selection, hiring, training, and supervision of CRAs as needed. Perform co-monitoring and training visits with CRAs.&nbsp;</li>\n<li>When required, act as the first escalation point for the resolution of site/patient issues or to address Sponsor concerns.</li>\n<li>May represent Director, Monitoring and Site Management or Manager, Clinical Site Management in BD initiatives with a site monitoring focus.</li>\n"},{"text":"Project Monitoring Lead","content":"\n<li>May be assigned Lead CRA role and manage monitoring services for a group of projects and/or CRAs on large/complex project(s) including directing/guiding day to day activities and review/approval of monitoring reports.</li>\n<li>Function as liaison between CRAs and other functional teams, escalating concerns and issues to management as needed.</li>\n<li>Participate and/or present at study team, kickoff and investigator meetings and act as primary contact to sponsors for all monitoring related issues.</li>\n"},{"text":"Site Recruitment and Setup ","content":"\n<li>Identify and recruit site investigators, coordinate the movement and delivery of trial materials, samples, tests and forms, including investigational product, protocols, SOPs, CRFs, project documents, forms and support tools.</li>\n<li>Ensure SOPs in place to optimize patient recruitment providing guidance to site teams of inclusion/exclusion criteria.</li>\n"},{"text":"Investigational Site Monitoring ","content":"\n<li>Primary clinical site contact.</li>\n<li>May act as primary contact for any questions or issues that arise from investigational sites.</li>\n<li>Oversee overall integrity of the study to promote positive working relationships with the site and staff.</li>\n<li>Facilitate and support site staff with access to study systems and ensure sites are compliant with project specific training requirements.</li>\n<li>Ensure all site related issues are followed until resolution.</li>\n<li>Coordinate delivery of clinical sites communications, collaborating with project teams, to ensure investigational sites are provided accurate ongoing data, updates, information and feedback on project/regulatory guidelines and objectives throughout the project lifecycle.</li>\n"},{"text":"Qualifications","content":"\n<li>The successful candidate will possess a minimum of a college diploma/degree and 4-6 years of related experience.</li>\n<li>The successful candidate must exhibit the following skills: self-motivation with strong communication skills and a commitment to achieving positive results.&nbsp;</li>\n<li>Strong attention to detail and keenness to understand the importance of building collaborative relationships to achieve results.&nbsp;</li>\n<li>Ability to engage in continuous learning and self-development.&nbsp;</li>\n<li>Ability to continually foster teamwork.</li>\n<li>For one CRA position supporting Flemish sites in Belgium, Dutch language skills are required.</li>\n"},{"text":"Working Conditions ","content":"\n<li>Home-based</li>\n<li>Regular travel</li>\n"}],"salaryRange":{"min":58000,"max":96500,"currency":"AUD","interval":"per-year-salary"},"text":"Sr. Clinical Research Associate (Australia)","country":"AU","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div><span style=\"font-size: 15px;\">Manage, deliver and/or perform full clinical site monitoring services for one or more projects, which may include multiple services, be complex in nature and/or run on a multinational scale.&nbsp; In-house based position, responsible for the design and oversight of project monitoring services including training, site/patient recruitment, site data/document management, monitoring project site budgets and regulatory filings that aligns with SOPs, study guidelines and GCP best practices.&nbsp; In the function of Lead CRA, will act as primary liaison between CRAs and project team and may be required to participate in the development of project plans, protocols, CRFs, communications or other monitoring forms, documents and tools. Represents the corporation by maintaining collaborative relationships with stakeholders.</span></div>","descriptionBodyPlain":"Manage, deliver and/or perform full clinical site monitoring services for one or more projects, which may include multiple services, be complex in nature and/or run on a multinational scale.  In-house based position, responsible for the design and oversight of project monitoring services including training, site/patient recruitment, site data/document management, monitoring project site budgets and regulatory filings that aligns with SOPs, study guidelines and GCP best practices.  In the function of Lead CRA, will act as primary liaison between CRAs and project team and may be required to participate in the development of project plans, protocols, CRFs, communications or other monitoring forms, documents and tools. Represents the corporation by maintaining collaborative relationships with stakeholders.\n","hostedUrl":"https://jobs.lever.co/alimentiv-2/45952406-28db-4d77-a961-d06e32c5dd53","applyUrl":"https://jobs.lever.co/alimentiv-2/45952406-28db-4d77-a961-d06e32c5dd53/apply"},{"additionalPlain":"Stay Alert to Recruitment Scams\nWe have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.\n","additional":"<div><span data-teams=\"true\"><strong>Stay Alert to Recruitment Scams</strong><br>We have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.</span></div>","categories":{"commitment":"Full-time, Permanent","department":"Clinical Services","location":"Brussels","team":"Clinical Study Delivery - Monitoring & Site Management","allLocations":["Brussels"]},"createdAt":1771613070918,"descriptionPlain":"Manage, deliver and/or perform full clinical site monitoring services for one or more projects, which may include multiple services, be complex in nature and/or run on a multinational scale.  In-house based position, responsible for the design and oversight of project monitoring services including training, site/patient recruitment, site data/document management, monitoring project site budgets and regulatory filings that aligns with SOPs, study guidelines and GCP best practices.  In the function of Lead CRA, will act as primary liaison between CRAs and project team and may be required to participate in the development of project plans, protocols, CRFs, communications or other monitoring forms, documents and tools. Represents the corporation by maintaining collaborative relationships with stakeholders.\n","description":"<div><span style=\"font-size: 15px;\">Manage, deliver and/or perform full clinical site monitoring services for one or more projects, which may include multiple services, be complex in nature and/or run on a multinational scale.&nbsp; In-house based position, responsible for the design and oversight of project monitoring services including training, site/patient recruitment, site data/document management, monitoring project site budgets and regulatory filings that aligns with SOPs, study guidelines and GCP best practices.&nbsp; In the function of Lead CRA, will act as primary liaison between CRAs and project team and may be required to participate in the development of project plans, protocols, CRFs, communications or other monitoring forms, documents and tools. Represents the corporation by maintaining collaborative relationships with stakeholders.</span></div>","id":"bf58c7fc-dd23-48bb-af71-632147d3d399","lists":[{"text":"Monitoring - Subject Expert ","content":"\n<li>Act as subject matter expert, mentor, coach and/or provide performance feedback to manager for peers.</li>\n<li>Assist with selection, hiring, training, and supervision of CRAs as needed. Perform co-monitoring and training visits with CRAs.&nbsp;</li>\n<li>When required, act as the first escalation point for the resolution of site/patient issues or to address Sponsor concerns.</li>\n<li>May represent Director, Monitoring and Site Management or Manager, Clinical Site Management in BD initiatives with a site monitoring focus.</li>\n"},{"text":"Project Monitoring Lead","content":"\n<li>May be assigned Lead CRA role and manage monitoring services for a group of projects and/or CRAs on large/complex project(s) including directing/guiding day to day activities and review/approval of monitoring reports.</li>\n<li>Function as liaison between CRAs and other functional teams, escalating concerns and issues to management as needed.</li>\n<li>Participate and/or present at study team, kickoff and investigator meetings and act as primary contact to sponsors for all monitoring related issues.</li>\n"},{"text":"Site Recruitment and Setup ","content":"\n<li>Identify and recruit site investigators, coordinate the movement and delivery of trial materials, samples, tests and forms, including investigational product, protocols, SOPs, CRFs, project documents, forms and support tools.</li>\n<li>Ensure SOPs in place to optimize patient recruitment providing guidance to site teams of inclusion/exclusion criteria.</li>\n"},{"text":"Investigational Site Monitoring ","content":"\n<li>Primary clinical site contact.</li>\n<li>May act as primary contact for any questions or issues that arise from investigational sites.</li>\n<li>Oversee overall integrity of the study to promote positive working relationships with the site and staff.</li>\n<li>Facilitate and support site staff with access to study systems and ensure sites are compliant with project specific training requirements.</li>\n<li>Ensure all site related issues are followed until resolution.</li>\n<li>Coordinate delivery of clinical sites communications, collaborating with project teams, to ensure investigational sites are provided accurate ongoing data, updates, information and feedback on project/regulatory guidelines and objectives throughout the project lifecycle.</li>\n"},{"text":"Qualifications ","content":"\n<li>The successful candidate will possess a minimum of a college diploma/degree and 4-6 years of related experience.</li>\n<li>Self-motivation with strong communication skills and a commitment to achieving positive results.&nbsp;</li>\n<li>Strong attention to detail and keenness to understand the importance of building collaborative relationships to achieve results.&nbsp;</li>\n<li>Critical thinking abilities</li>\n<li>Ability to regularly travel to sites.</li>\n<li>Must be fluent in English, Dutch, and French</li>\n"},{"text":"Working Conditions ","content":"\n<li>Home-based</li>\n<li>Regular travel is required</li>\n"}],"salaryRange":{"currency":"EUR","interval":"per-year-salary","min":58000,"max":78500},"salaryDescription":"<div>\n<div><strong>Sign-On Bonus:</strong> This role includes a one-time sign-on bonus in recognition of playing a key role in our initial expansion in this area. (€3,000 )</div>\n<div>&nbsp;</div>\n<div>Additionally:</div>\n<ul>\n<li>Annual Bonus (Short Term Incentive Program) target = <strong>8% </strong>of annual salary</li>\n<li>A monthly stipend of €157.83 (pro-rated based on hours of work), to be paid with their regular payroll/added to their taxable income. This is intended to offset the business use of the employee’s communication costs (internet, VoIP, land line, etc.)</li>\n<li>Monthly Cell phone stipend&nbsp; (€40)</li>\n<li data-list-item-id=\"ec61cd13f0361cc604da53474d1dd75f7\">A one time expense reimbursement of up to €500 (local currency) to purchase other office items such as a scanner/printer, an extra monitor, office furniture and supplies, etc.</li>\n<li>Mileage reimbursement&nbsp;for travel&nbsp;</li>\n</ul>\n</div>","salaryDescriptionPlain":"Sign-On Bonus: This role includes a one-time sign-on bonus in recognition of playing a key role in our initial expansion in this area. (€3,000 )\n \nAdditionally:\nAnnual Bonus (Short Term Incentive Program) target = 8% of annual salary\nA monthly stipend of €157.83 (pro-rated based on hours of work), to be paid with their regular payroll/added to their taxable income. This is intended to offset the business use of the employee’s communication costs (internet, VoIP, land line, etc.)\nMonthly Cell phone stipend  (€40)\nA one time expense reimbursement of up to €500 (local currency) to purchase other office items such as a scanner/printer, an extra monitor, office furniture and supplies, etc.\nMileage reimbursement for travel \n","text":"Sr. Clinical Research Associate (Belgium)","country":"BE","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div><span style=\"font-size: 15px;\">Manage, deliver and/or perform full clinical site monitoring services for one or more projects, which may include multiple services, be complex in nature and/or run on a multinational scale.&nbsp; In-house based position, responsible for the design and oversight of project monitoring services including training, site/patient recruitment, site data/document management, monitoring project site budgets and regulatory filings that aligns with SOPs, study guidelines and GCP best practices.&nbsp; In the function of Lead CRA, will act as primary liaison between CRAs and project team and may be required to participate in the development of project plans, protocols, CRFs, communications or other monitoring forms, documents and tools. Represents the corporation by maintaining collaborative relationships with stakeholders.</span></div>","descriptionBodyPlain":"Manage, deliver and/or perform full clinical site monitoring services for one or more projects, which may include multiple services, be complex in nature and/or run on a multinational scale.  In-house based position, responsible for the design and oversight of project monitoring services including training, site/patient recruitment, site data/document management, monitoring project site budgets and regulatory filings that aligns with SOPs, study guidelines and GCP best practices.  In the function of Lead CRA, will act as primary liaison between CRAs and project team and may be required to participate in the development of project plans, protocols, CRFs, communications or other monitoring forms, documents and tools. Represents the corporation by maintaining collaborative relationships with stakeholders.\n","hostedUrl":"https://jobs.lever.co/alimentiv-2/bf58c7fc-dd23-48bb-af71-632147d3d399","applyUrl":"https://jobs.lever.co/alimentiv-2/bf58c7fc-dd23-48bb-af71-632147d3d399/apply"},{"additionalPlain":"Stay Alert to Recruitment Scams\nWe have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.\n","additional":"<div><span data-teams=\"true\"><strong>Stay Alert to Recruitment Scams</strong><br>We have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.</span></div>","categories":{"commitment":"Full-time, Permanent","department":"Clinical Services","location":"Bucharest","team":"Clinical Study Delivery - Monitoring & Site Management","allLocations":["Bucharest"]},"createdAt":1773424783699,"descriptionPlain":"Manage, deliver and/or perform full clinical site monitoring services for one or more projects, which may include multiple services, be complex in nature and/or run on a multinational scale.  In-house based position, responsible for the design and oversight of project monitoring services including training, site/patient recruitment, site data/document management, monitoring project site budgets and regulatory filings that aligns with SOPs, study guidelines and GCP best practices.  In the function of Lead CRA, will act as primary liaison between CRAs and project team and may be required to participate in the development of project plans, protocols, CRFs, communications or other monitoring forms, documents and tools. Represents the corporation by maintaining collaborative relationships with stakeholders.\n","description":"<div><span style=\"font-size: 15px;\">Manage, deliver and/or perform full clinical site monitoring services for one or more projects, which may include multiple services, be complex in nature and/or run on a multinational scale.&nbsp; In-house based position, responsible for the design and oversight of project monitoring services including training, site/patient recruitment, site data/document management, monitoring project site budgets and regulatory filings that aligns with SOPs, study guidelines and GCP best practices.&nbsp; In the function of Lead CRA, will act as primary liaison between CRAs and project team and may be required to participate in the development of project plans, protocols, CRFs, communications or other monitoring forms, documents and tools. Represents the corporation by maintaining collaborative relationships with stakeholders.</span></div>","id":"21cb994c-2786-4abb-9419-079b99cae778","lists":[{"text":"Monitoring - Subject Expert ","content":"\n<li>Act as subject matter expert, mentor, coach and/or provide performance feedback to manager for peers.</li>\n<li>Assist with selection, hiring, training, and supervision of CRAs as needed. Perform co-monitoring and training visits with CRAs.&nbsp;</li>\n<li>When required, act as the first escalation point for the resolution of site/patient issues or to address Sponsor concerns.</li>\n<li>May represent Director, Monitoring and Site Management or Manager, Clinical Site Management in BD initiatives with a site monitoring focus.</li>\n"},{"text":"Project Monitoring Lead","content":"\n<li>May be assigned Lead CRA role and manage monitoring services for a group of projects and/or CRAs on large/complex project(s) including directing/guiding day to day activities and review/approval of monitoring reports.</li>\n<li>Function as liaison between CRAs and other functional teams, escalating concerns and issues to management as needed.</li>\n<li>Participate and/or present at study team, kickoff and investigator meetings and act as primary contact to sponsors for all monitoring related issues.</li>\n"},{"text":"Site Recruitment and Setup ","content":"\n<li>Identify and recruit site investigators, coordinate the movement and delivery of trial materials, samples, tests and forms, including investigational product, protocols, SOPs, CRFs, project documents, forms and support tools.</li>\n<li>Ensure SOPs in place to optimize patient recruitment providing guidance to site teams of inclusion/exclusion criteria.</li>\n"},{"text":"Investigational Site Monitoring ","content":"\n<li>Primary clinical site contact.</li>\n<li>May act as primary contact for any questions or issues that arise from investigational sites.</li>\n<li>Oversee overall integrity of the study to promote positive working relationships with the site and staff.</li>\n<li>Facilitate and support site staff with access to study systems and ensure sites are compliant with project specific training requirements.</li>\n<li>Ensure all site related issues are followed until resolution.</li>\n<li>Coordinate delivery of clinical sites communications, collaborating with project teams, to ensure investigational sites are provided accurate ongoing data, updates, information and feedback on project/regulatory guidelines and objectives throughout the project lifecycle.</li>\n"},{"text":"Qualifications ","content":"\n<li>The successful candidate will possess a minimum of a college diploma/degree and 4-6 years of related experience.</li>\n<li>The successful candidate must exhibit the following skills: self-motivation with strong communication skills and a commitment to achieving positive results.&nbsp;</li>\n<li>Strong attention to detail and keenness to understand the importance of building collaborative relationships to achieve results.&nbsp;</li>\n<li>Ability to engage in continuous learning and self-development.&nbsp;</li>\n<li>Ability to continually foster teamwork.</li>\n"},{"text":"Working Conditions ","content":"\n<li>Home-based</li>\n<li>Regular travel</li>\n"},{"text":"","content":"<div>\n<div><strong data-olk-copy-source=\"MessageBody\">Asociat Senior de Cercetare Clinică (România)</strong>&nbsp;</div>\n<div>București | Servicii Clinice – Livrare Studii Clinice - Monitorizare și Management de Sit / Full-time, Permanent / Remote</div>\n<div>&nbsp;</div>\n<div>Gestionați, livrați și/sau efectuați servicii complete de monitorizare a siturilor clinice pentru unul sau mai multe proiecte, care pot include servicii multiple, pot fi complexe prin natura lor și/sau se desfășoară la scară multinațională. Poziție bazată intern, responsabilă de proiectarea și supravegherea serviciilor de monitorizare a proiectelor, inclusiv formarea, recrutarea siturilor/pacienților, gestionarea datelor/documentelor de sit, monitorizarea bugetelor de sit ale proiectelor și dosarele de reglementare, în conformitate cu SOPs, ghidurile studiului și bunele practici GCP. În funcția de CRA Principal, va acționa ca legătură principală între CRAs și echipa de proiect și poate fi solicitat să participe la elaborarea planurilor de proiect, protocoalelor, CRF-urilor, comunicărilor sau altor formulare, documente și instrumente de monitorizare. Reprezintă compania prin menținerea unor relații de colaborare cu părțile interesate.</div>\n<hr>\n<div><strong>Monitorizare - Expert în Domeniu</strong></div>\n\n<li>Acționați ca expert în domeniu, mentor, coach și/sau furnizați feedback de performanță managerului pentru colegi.</li>\n<li>Asistați la selecția, angajarea, formarea și supervizarea CRAs după caz. Efectuați vizite de co-monitorizare și formare cu CRAs.</li>\n<li>Când este necesar, acționați ca prim punct de escaladare pentru rezolvarea problemelor de sit/pacient sau pentru a aborda îngrijorările Sponsorului.</li>\n<li>Poate reprezenta Directorul, Monitorizare și Management de Sit sau Managerul, Management Sit Clinic în inițiative BD cu accent pe monitorizarea sitului.</li>\n\n<hr>\n<div><strong>Responsabil Principal de Monitorizare a Proiectului</strong></div>\n\n<li>Poate fi desemnat în rolul de CRA Principal și gestionează serviciile de monitorizare pentru un grup de proiecte și/sau CRAs pe proiecte mari/complexe, inclusiv direcționarea/ghidarea activităților zilnice și revizuirea/aprobarea rapoartelor de monitorizare.</li>\n<li>Funcționează ca legătură între CRAs și alte echipe funcționale, escaladând îngrijorările și problemele către management după caz.</li>\n<li>Participați și/sau prezentați la întâlnirile echipei de studiu, ședințele de lansare și întâlnirile investigatorilor și acționați ca principal contact al sponsorilor pentru toate problemele legate de monitorizare.</li>\n\n<hr>\n<div><strong>Recrutarea și Configurarea Sitului</strong></div>\n\n<li>Identificați și recrutați investigatori de sit, coordonați mișcarea și livrarea materialelor de studiu, probelor, testelor și formularelor, inclusiv produsul investigațional, protocoalele, SOPs, CRF-urile, documentele de proiect, formularele și instrumentele de suport.</li>\n<li>Asigurați-vă că SOPs sunt în vigoare pentru a optimiza recrutarea pacienților, oferind îndrumare echipelor de sit cu privire la criteriile de includere/excludere.</li>\n\n<hr>\n<div><strong>Monitorizarea Sitului de Investigație</strong></div>\n\n<li>Contact principal al sitului clinic.</li>\n<li>Poate acționa ca principal contact pentru orice întrebări sau probleme care apar de la siturile de investigație.</li>\n<li>Supravegheați integritatea generală a studiului pentru a promova relații de lucru pozitive cu situl și personalul.</li>\n<li>Facilitați și sprijiniți personalul de sit cu accesul la sistemele studiului și asigurați-vă că siturile respectă cerințele de formare specifice proiectului.</li>\n<li>Asigurați-vă că toate problemele legate de sit sunt urmărite până la rezolvare.</li>\n<li>Coordonați livrarea comunicărilor siturilor clinice, colaborând cu echipele de proiect, pentru a vă asigura că siturile de investigație primesc date, actualizări, informații și feedback precise și continue privind ghidurile și obiectivele proiectului/reglementare pe parcursul ciclului de viață al proiectului.</li>\n\n<hr>\n<div><strong>Calificări</strong></div>\n\n<li>Candidatul de succes va poseda cel puțin o diplomă de colegiu/licență și 4-6 ani de experiență relevantă.</li>\n<li>Candidatul de succes trebuie să demonstreze următoarele competențe: automotivare cu abilități puternice de comunicare și angajament față de obținerea de rezultate pozitive.</li>\n<li>Atenție deosebită la detalii și dorința de a înțelege importanța construirii unor relații de colaborare pentru atingerea rezultatelor.</li>\n<li>Capacitatea de a se angaja în învățare continuă și auto-dezvoltare.</li>\n<li>Capacitatea de a promova continuu munca în echipă.</li>\n\n<hr>\n<div><strong>Condiții de Muncă</strong></div>\n\n<li>Lucru de acasă</li>\n<li>Călătorii regulate</li>\n<li>200.000 - 250.000 lei pe an</li>\n\n<div><strong>Bonus la angajare:</strong>&nbsp;Acest rol include un bonus unic la angajare în recunoașterea rolului cheie în expansiunea noastră inițială în această zonă. (~15.225 RON)</div>\n<div>&nbsp;</div>\n<div><strong>Suplimentar:</strong></div>\n\n<li>Bonus anual (Program de Stimulente pe Termen Scurt) țintă = 8% din salariul anual</li>\n<li>O indemnizație lunară de 400 RON (calculată proporțional în funcție de orele de muncă), plătită odată cu salariul regulat/adăugată la venitul impozabil. Aceasta este destinată să compenseze utilizarea în scop profesional a costurilor de comunicare ale angajatului (internet, VoIP, linie fixă etc.)</li>\n<li>Indemnizație lunară pentru telefon mobil (50 RON)</li>\n<li>O rambursare unică de cheltuieli de până la 500,00 (monedă locală) pentru achiziționarea altor articole de birou, cum ar fi un scaner/imprimantă, un monitor suplimentar, mobilier de birou și consumabile etc.</li>\n<li>Rambursarea kilometrajului pentru călătorii</li>\n\n<hr>\n<div>Vă reamintesc că acest anunț conține informații despre compensații și beneficii specifice rolului -- asigurați-vă că datele sunt revizuite de echipa relevantă înainte de publicare, în conformitate cu politicile Alimentiv.</div>\n<div>&nbsp;</div>\n</div>"}],"salaryRange":{"min":200000,"max":250000,"currency":"RON","interval":"per-year-salary"},"salaryDescription":"<div><strong>Sign-On Bonus:</strong> This role includes a one-time sign-on bonus in recognition of playing a key role in our initial expansion in this area. (~15,225 RON)</div>\n<div>&nbsp;</div>\n<div>Additionally:</div>\n<ul>\n<li>Annual Bonus (Short Term Incentive Program) target = <strong>8% </strong>of annual salary</li>\n<li>A monthly stipend of 400 RON (pro-rated based on hours of work), to be paid with their regular payroll/added to their taxable income. This is intended to offset the business use of the employee’s communication costs (internet, VoIP, land line, etc.)</li>\n<li>Monthly Cell phone stipend&nbsp; (RON 50)</li>\n<li data-list-item-id=\"ec61cd13f0361cc604da53474d1dd75f7\">A one time&nbsp;expense reimbursement of up to 500.00 (local currency) to purchase other office items such as a scanner/printer, an extra monitor, office furniture and supplies, etc.</li>\n<li>Mileage reimbursement&nbsp;for travel&nbsp;</li>\n</ul>","salaryDescriptionPlain":"Sign-On Bonus: This role includes a one-time sign-on bonus in recognition of playing a key role in our initial expansion in this area. (~15,225 RON)\n \nAdditionally:\nAnnual Bonus (Short Term Incentive Program) target = 8% of annual salary\nA monthly stipend of 400 RON (pro-rated based on hours of work), to be paid with their regular payroll/added to their taxable income. This is intended to offset the business use of the employee’s communication costs (internet, VoIP, land line, etc.)\nMonthly Cell phone stipend  (RON 50)\nA one time expense reimbursement of up to 500.00 (local currency) to purchase other office items such as a scanner/printer, an extra monitor, office furniture and supplies, etc.\nMileage reimbursement for travel \n","text":"Sr. Clinical Research Associate (Romania)","country":"RO","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div><span style=\"font-size: 15px;\">Manage, deliver and/or perform full clinical site monitoring services for one or more projects, which may include multiple services, be complex in nature and/or run on a multinational scale.&nbsp; In-house based position, responsible for the design and oversight of project monitoring services including training, site/patient recruitment, site data/document management, monitoring project site budgets and regulatory filings that aligns with SOPs, study guidelines and GCP best practices.&nbsp; In the function of Lead CRA, will act as primary liaison between CRAs and project team and may be required to participate in the development of project plans, protocols, CRFs, communications or other monitoring forms, documents and tools. Represents the corporation by maintaining collaborative relationships with stakeholders.</span></div>","descriptionBodyPlain":"Manage, deliver and/or perform full clinical site monitoring services for one or more projects, which may include multiple services, be complex in nature and/or run on a multinational scale.  In-house based position, responsible for the design and oversight of project monitoring services including training, site/patient recruitment, site data/document management, monitoring project site budgets and regulatory filings that aligns with SOPs, study guidelines and GCP best practices.  In the function of Lead CRA, will act as primary liaison between CRAs and project team and may be required to participate in the development of project plans, protocols, CRFs, communications or other monitoring forms, documents and tools. Represents the corporation by maintaining collaborative relationships with stakeholders.\n","hostedUrl":"https://jobs.lever.co/alimentiv-2/21cb994c-2786-4abb-9419-079b99cae778","applyUrl":"https://jobs.lever.co/alimentiv-2/21cb994c-2786-4abb-9419-079b99cae778/apply"},{"additionalPlain":"Stay Alert to Recruitment Scams\nWe have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.\n","additional":"<div><span data-teams=\"true\"><strong>Stay Alert to Recruitment Scams</strong><br>We have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.</span></div>","categories":{"commitment":"Full-time, Permanent","department":"Clinical Services","location":"Berlin","team":"Clinical Services - Statistics - Statistics & Programming","allLocations":["Berlin"]},"createdAt":1776126234866,"descriptionPlain":"Responsible for the application of biostatistical methods to support clinical trials and data management, including statistical planning, design, analysis, and reporting throughout the project life cycle in accordance with project, organizational and regulatory standards. Act as subject matter expert, providing statistical support to project teams, quality/study auditors, and external stakeholders. Participate in the promotion of Alimentiv as a global research organization, by contributing to the development, publishing, and reporting of project data. Lead and develop a group of statisticians and SAS Programmers.\n","description":"<div>Responsible for the application of biostatistical methods to support clinical trials and data management, including statistical planning, design, analysis, and reporting throughout the project life cycle in accordance with project, organizational and regulatory standards. Act as subject matter expert, providing statistical support to project teams, quality/study auditors, and external stakeholders. Participate in the promotion of Alimentiv as a global research organization, by contributing to the development, publishing, and reporting of project data. Lead and develop a group of statisticians and SAS Programmers.</div>","id":"bd8b7558-0b1a-4419-87ac-8d584d14c2e6","lists":[{"text":"Analysis Services ","content":"\n<li>Carry out statistical analyses and provide direction to programmers, using standard software packages to interpret and translate results within a statistical framework into biomedical terms and prepare statistical data results for inclusion in reports and research papers that meet trial, organizational and regulatory best practices, and standards.</li>\n"},{"text":"Academic and Project Research Support","content":"\n<li>Working in conjunction with the Director of Academic Research, convert and present new and novel biometrical trial technologies, processes and findings into publishable and promotable scientific processes and results.</li>\n<li>Provide statistical expertise and guidance based on established methodologies throughout the project life cycle in the areas of study policies, protocols, implementation timelines and processes, data interpretation and publication of results. Work with data management team to ensure data captured incorporates and corresponds to project protocols and requirements.</li>\n"},{"text":"Statistical Analysis/Data Collection Planning and Study Report Support","content":"\n<li>Prepare statistical analysis plan and oversee project data collection, management, and analysis, with input from the project teams, that incorporates the type of information collected, sample size, randomization procedures, table and listing shells, project statistical policies, protocols, and methodology to be used to appropriately translate scientific questions into statistical hypotheses.</li>\n<li>Assist medical director(s) and/or technical writers by preparing statistical section of study report, publications and/or presentations ensuring statistical analyses adheres to trial, sponsor, organizational and regulatory requirements, and best practices.</li>\n"},{"text":"Personnel Management","content":"\n<li>Assign/schedule studies and tasks to functional unit to ensure project needs are met.</li>\n<li>Responsible for performance management (staff evaluation, performance improvement and lost time management) of direct reports.</li>\n<li>Provide direction and support to project financial coordinators and promote team development by providing coaching, mentoring, and training.</li>\n<li>Develop and deliver ongoing training on document user systems, document naming and department Quality System processes to peers and stakeholders, including new employee orientation.</li>\n"},{"text":"Qualifications","content":"\n<li>The successful candidate should hold a minimum of an undergraduate degree with professional certifications and 4-6 years of professional experience. A Masters' degree in Statistics or Biostatistics specialty is preferred.</li>\n<li>Experience in the industry, or in an academic setting is preferred.</li>\n<li>Very strong communication skills is a must.</li>\n<li>Must be fluent in German</li>\n"}],"salaryRange":{"min":67000,"max":112000,"currency":"EUR","interval":"per-year-salary"},"text":"Sr. Statistician","country":"DE","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>Responsible for the application of biostatistical methods to support clinical trials and data management, including statistical planning, design, analysis, and reporting throughout the project life cycle in accordance with project, organizational and regulatory standards. Act as subject matter expert, providing statistical support to project teams, quality/study auditors, and external stakeholders. Participate in the promotion of Alimentiv as a global research organization, by contributing to the development, publishing, and reporting of project data. Lead and develop a group of statisticians and SAS Programmers.</div>","descriptionBodyPlain":"Responsible for the application of biostatistical methods to support clinical trials and data management, including statistical planning, design, analysis, and reporting throughout the project life cycle in accordance with project, organizational and regulatory standards. Act as subject matter expert, providing statistical support to project teams, quality/study auditors, and external stakeholders. Participate in the promotion of Alimentiv as a global research organization, by contributing to the development, publishing, and reporting of project data. Lead and develop a group of statisticians and SAS Programmers.\n","hostedUrl":"https://jobs.lever.co/alimentiv-2/bd8b7558-0b1a-4419-87ac-8d584d14c2e6","applyUrl":"https://jobs.lever.co/alimentiv-2/bd8b7558-0b1a-4419-87ac-8d584d14c2e6/apply"},{"additional":"","additionalPlain":"","categories":{"commitment":"Full-time, Permanent","department":"Clinical Services","location":"Berlin","team":"Clinical Services - TMF Operations","allLocations":["Berlin","Budapest","Krakow","Warsaw","Bucharest","Rio de Janeiro","Sao Paulo","Fortaleza","Wroclaw","Frankfurt"]},"createdAt":1780099697085,"descriptionPlain":"ABOUT ALIMENTIV\nAlimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.\nWe operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.\nIf you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you.\nTHE OPPORTUNITY\n \nThe Sr. TMF Lead provides expert, study-facing TMF oversight for assigned studies and complex programs, ensuring TMF\nquality, compliance, and continuous inspection readiness. Acting as a TMF subject matter expert (SME), the role aligns\nsponsor-specific TMF requirements with CRO processes, applies risk-based TMF management practices, and leads TMF\nexecution from study start-up through close-out. The Sr. TMF Lead independently advises sponsors and internal stakeholders,\nmentors TMF staff, and contributes subject matter expertise to TMF process and system improvements. \n \nPositions available: 1; this opportunity is cross-listed in multiple locations. At this time, the position is open to those residing in Germany, Brazil, Poland, Hungary, and Romania. \nClosing date: June 12th, 2026, or until successful candidate identified. \n","description":"<div>\n<p><strong>ABOUT ALIMENTIV</strong></p>\n<p>Alimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.</p>\n<p>We operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.</p>\n<p>If you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you.</p>\n<strong>THE OPPORTUNITY</strong></div>\n<div>&nbsp;</div>\n<div>The Sr. TMF Lead provides expert, study-facing TMF oversight for assigned studies and complex programs, ensuring TMF<br>quality, compliance, and continuous inspection readiness. Acting as a TMF subject matter expert (SME), the role aligns<br>sponsor-specific TMF requirements with CRO processes, applies risk-based TMF management practices, and leads TMF<br>execution from study start-up through close-out. The Sr. TMF Lead independently advises sponsors and internal stakeholders,<br>mentors TMF staff, and contributes subject matter expertise to TMF process and system improvements.&nbsp;</div>\n<div>&nbsp;</div>\n<div><strong>Positions available</strong>: 1; this opportunity is cross-listed in multiple locations. At this time, the position is open to those residing in Germany, Brazil, Poland, Hungary, and Romania.&nbsp;</div>\n<div><strong>Closing date</strong>: June 12th, 2026, or until successful candidate identified.&nbsp;</div>","id":"0cedadfe-4084-430e-84d5-054cd10e0606","lists":[{"text":"The role:","content":"<div><strong>Individual TMF Delivery (40–45%)</strong></div>\n\n<li>Serve as TMF Lead for complex, high-risk, or strategically important studies or programs.</li>\n<li>Provide end-to-end TMF oversight from study start-up through close-out, transfer, and archival.</li>\n<li>Utilize TMF metrics, KPIs, and risk-based assessments to monitor TMF health and inspection readiness.</li>\n<li>Partner with Project Management and Functional Leads to proactively manage TMF deliverables and risks.</li>\n<li>Ensure TMF oversight reports and status updates are delivered to sponsors and internal stakeholders on a defined<br>cadence.</li>\n<li>Lead study-level audit and inspection readiness activities and support audit responses.</li>\n\n<div><strong>Program / Product Line TMF Oversight &amp; Delivery (25–30%)</strong></div>\n\n<li>Provide strategic, study-facing oversight across assigned studies, programs, or product lines to ensure consistent<br>TMF execution.</li>\n<li>Align sponsor-specific TMF requirements with CRO processes and filing models, ensuring clear expectations for<br>study teams.</li>\n<li>Utilize TMF metrics, KPIs, and risk-based assessments to ensure TMFs meet standards for quality, completeness,<br>timeliness, and inspection readiness.</li>\n<li>Identify cross-study or systemic trends and risks; develop and drive mitigation strategies, corrective actions, and<br>targeted training initiatives.</li>\n<li>Act as TMF SME for TMF Management Plans, file and guidance.</li>\n<li>Support sponsor-facing TMF strategy discussions and governance forums.</li>\n<li>Act as escalation point for complex TMF risks and compliance issues.</li>\n\n<div><strong>Study-Facing Process Alignment &amp; Continuous Improvement (10–15%)</strong></div>\n\n<li>Ensure consistent application of TMF processes, standards, and quality expectations across assigned studies.</li>\n<li>Identify study-facing process gaps, inefficiencies, or compliance risks and escalate recommendations to TMF<br>Operations (TMFO) and Quality.</li>\n<li>Contribute subject matter expertise to TMF process updates, SOP revisions, and system enhancements led by<br>TMFO.</li>\n<li>Support implementation of updated TMF processes, tools, and system changes within study teams.</li>\n\n<div><strong>Training, Mentoring and Onboarding (10–15%)</strong></div>\n\n<li>Provide advanced mentoring and TMF oversight guidance to TMF Leads, TMFAs, and TMFCs to ensure consistent<br>application of TMF standards.&nbsp;</li>\n<li>Develop and deliver advanced TMF training materials for study teams and functional stakeholders.</li>\n<li>Partner with Quality Training &amp; Compliance (QTC) to ensure training reflects current processes and inspection<br>expectations.</li>\n<li>Serve as a knowledge resource for complex TMF scenarios, regulatory expectations, and inspection readiness.</li>\n"},{"text":"About You:","content":"<div><strong>Education &amp; Experience:&nbsp;</strong></div>\n\n<li>Minimum 7-9 years of recent, related experience in TMF function within a Contract Research Organization, along with an Honour's Bachelor's degree</li>\n<li>Equivalent combination of education and experience may be considered.&nbsp;</li>\n<li>Strong working knowledge of ICH-GCP, 21 CFR Part 11, EU CTR, and other global regulatory requirements</li>\n<li>TMF Reference Model and risk-based TMF management principles</li>\n<li>Experience with inspection readiness activities (FDA, EMA, MHRA, etc) and TMF audits</li>\n<li>Procedural gap analysis and issue resolution in TMF contexts</li>\n<li>Experience with leading eTMF platforms (e.g., Veeva Vault, Wingspan)</li>\n<li>TMF governance, quality oversight, and inspection readiness</li>\n<li>Strong organizational, analytical, and problem-solving skills</li>\n<li>Excellent stakeholder management, communication, and client-facing skills</li>\n<li>Ability to work effectively in a global, matrixed environment</li>\n<li>Program-level or portfolio TMF oversight experience, including study alignment and risk management within a<br>sponsor or CRO environment</li>\n<li>Demonstrated ability to advise sponsors and cross-functional stakeholders on TMF strategy and risk management</li>\n<li>Certifications related to clinical research, quality, or regulatory compliance (e.g., SOCRA, ACRP, RAPS, TMF<br>certification) would be an asset</li>\n<li>Continuous improvement mindset and ability to provide study-level process guidance</li>\n"}],"salaryRange":{"min":59500,"max":99500,"currency":"EUR","interval":"per-year-salary"},"salaryDescription":"<div>+ Bonus&nbsp;</div>\n<div>&nbsp;</div>\n<div>Please note that the above range reflects the full spectrum of compensation for candidates located in Germany - our Talent Acquisition team will be happy to discuss specific local compensation at time of interview.&nbsp;</div>","salaryDescriptionPlain":"+ Bonus \n \nPlease note that the above range reflects the full spectrum of compensation for candidates located in Germany - our Talent Acquisition team will be happy to discuss specific local compensation at time of interview. \n","text":"Sr. TMF Lead","country":"DE","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>\n<p><strong>ABOUT ALIMENTIV</strong></p>\n<p>Alimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.</p>\n<p>We operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.</p>\n<p>If you want to do meaningful work, build something real, and invest back in research that changes lives &mdash; we want to meet you.</p>\n<strong>THE OPPORTUNITY</strong></div>\n<div>&nbsp;</div>\n<div>The Sr. TMF Lead provides expert, study-facing TMF oversight for assigned studies and complex programs, ensuring TMF<br>quality, compliance, and continuous inspection readiness. Acting as a TMF subject matter expert (SME), the role aligns<br>sponsor-specific TMF requirements with CRO processes, applies risk-based TMF management practices, and leads TMF<br>execution from study start-up through close-out. The Sr. TMF Lead independently advises sponsors and internal stakeholders,<br>mentors TMF staff, and contributes subject matter expertise to TMF process and system improvements.&nbsp;</div>\n<div>&nbsp;</div>\n<div><strong>Positions available</strong>: 1; this opportunity is cross-listed in multiple locations. At this time, the position is open to those residing in Germany, Brazil, Poland, Hungary, and Romania.&nbsp;</div>\n<div><strong>Closing date</strong>: June 12th, 2026, or until successful candidate identified.&nbsp;</div>","descriptionBodyPlain":"ABOUT ALIMENTIV\nAlimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.\nWe operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.\nIf you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you.\nTHE OPPORTUNITY\n \nThe Sr. TMF Lead provides expert, study-facing TMF oversight for assigned studies and complex programs, ensuring TMF\nquality, compliance, and continuous inspection readiness. Acting as a TMF subject matter expert (SME), the role aligns\nsponsor-specific TMF requirements with CRO processes, applies risk-based TMF management practices, and leads TMF\nexecution from study start-up through close-out. The Sr. TMF Lead independently advises sponsors and internal stakeholders,\nmentors TMF staff, and contributes subject matter expertise to TMF process and system improvements. \n \nPositions available: 1; this opportunity is cross-listed in multiple locations. At this time, the position is open to those residing in Germany, Brazil, Poland, Hungary, and Romania. \nClosing date: June 12th, 2026, or until successful candidate identified. \n","hostedUrl":"https://jobs.lever.co/alimentiv-2/0cedadfe-4084-430e-84d5-054cd10e0606","applyUrl":"https://jobs.lever.co/alimentiv-2/0cedadfe-4084-430e-84d5-054cd10e0606/apply"},{"additional":"","additionalPlain":"","categories":{"commitment":"Full-time, Permanent","department":"Clinical Services","location":"London","team":"Clinical Services - TMF Operations","allLocations":["London","Belfast","Cambridge","Edinburgh","Manchester","Glasgow","Oxford"]},"createdAt":1780688382443,"descriptionPlain":"ABOUT ALIMENTIV\nAlimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.\nWe operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.\nIf you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you.\nTHE OPPORTUNITY\n \nThe Sr. TMF Lead provides expert, study-facing TMF oversight for assigned studies and complex programs, ensuring TMF\nquality, compliance, and continuous inspection readiness. Acting as a TMF subject matter expert (SME), the role aligns\nsponsor-specific TMF requirements with CRO processes, applies risk-based TMF management practices, and leads TMF\nexecution from study start-up through close-out. The Sr. TMF Lead independently advises sponsors and internal stakeholders,\nmentors TMF staff, and contributes subject matter expertise to TMF process and system improvements. \n \nPositions available: 1; this opportunity is cross-listed in multiple locations. At this time, the position is open to those residing in Germany, Brazil, Poland, Hungary, and Romania. \nClosing date: June 12th, 2026, or until successful candidate identified. \n","description":"<div>\n<p><strong>ABOUT ALIMENTIV</strong></p>\n<p>Alimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.</p>\n<p>We operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.</p>\n<p>If you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you.</p>\n<strong>THE OPPORTUNITY</strong></div>\n<div>&nbsp;</div>\n<div>The Sr. TMF Lead provides expert, study-facing TMF oversight for assigned studies and complex programs, ensuring TMF<br>quality, compliance, and continuous inspection readiness. Acting as a TMF subject matter expert (SME), the role aligns<br>sponsor-specific TMF requirements with CRO processes, applies risk-based TMF management practices, and leads TMF<br>execution from study start-up through close-out. The Sr. TMF Lead independently advises sponsors and internal stakeholders,<br>mentors TMF staff, and contributes subject matter expertise to TMF process and system improvements.&nbsp;</div>\n<div>&nbsp;</div>\n<div><strong>Positions available</strong>: 1; this opportunity is cross-listed in multiple locations. At this time, the position is open to those residing in Germany, Brazil, Poland, Hungary, and Romania.&nbsp;</div>\n<div><strong>Closing date</strong>: June 12th, 2026, or until successful candidate identified.&nbsp;</div>","id":"295cd4ae-342e-4316-a7ed-012cd49c4f7c","lists":[{"text":"The role:","content":"<div><strong>Individual TMF Delivery (40–45%)</strong></div>\n\n<li>Serve as TMF Lead for complex, high-risk, or strategically important studies or programs.</li>\n<li>Provide end-to-end TMF oversight from study start-up through close-out, transfer, and archival.</li>\n<li>Utilize TMF metrics, KPIs, and risk-based assessments to monitor TMF health and inspection readiness.</li>\n<li>Partner with Project Management and Functional Leads to proactively manage TMF deliverables and risks.</li>\n<li>Ensure TMF oversight reports and status updates are delivered to sponsors and internal stakeholders on a defined<br>cadence.</li>\n<li>Lead study-level audit and inspection readiness activities and support audit responses.</li>\n\n<div><strong>Program / Product Line TMF Oversight &amp; Delivery (25–30%)</strong></div>\n\n<li>Provide strategic, study-facing oversight across assigned studies, programs, or product lines to ensure consistent<br>TMF execution.</li>\n<li>Align sponsor-specific TMF requirements with CRO processes and filing models, ensuring clear expectations for<br>study teams.</li>\n<li>Utilize TMF metrics, KPIs, and risk-based assessments to ensure TMFs meet standards for quality, completeness,<br>timeliness, and inspection readiness.</li>\n<li>Identify cross-study or systemic trends and risks; develop and drive mitigation strategies, corrective actions, and<br>targeted training initiatives.</li>\n<li>Act as TMF SME for TMF Management Plans, file and guidance.</li>\n<li>Support sponsor-facing TMF strategy discussions and governance forums.</li>\n<li>Act as escalation point for complex TMF risks and compliance issues.</li>\n\n<div><strong>Study-Facing Process Alignment &amp; Continuous Improvement (10–15%)</strong></div>\n\n<li>Ensure consistent application of TMF processes, standards, and quality expectations across assigned studies.</li>\n<li>Identify study-facing process gaps, inefficiencies, or compliance risks and escalate recommendations to TMF<br>Operations (TMFO) and Quality.</li>\n<li>Contribute subject matter expertise to TMF process updates, SOP revisions, and system enhancements led by<br>TMFO.</li>\n<li>Support implementation of updated TMF processes, tools, and system changes within study teams.</li>\n\n<div><strong>Training, Mentoring and Onboarding (10–15%)</strong></div>\n\n<li>Provide advanced mentoring and TMF oversight guidance to TMF Leads, TMFAs, and TMFCs to ensure consistent<br>application of TMF standards.&nbsp;</li>\n<li>Develop and deliver advanced TMF training materials for study teams and functional stakeholders.</li>\n<li>Partner with Quality Training &amp; Compliance (QTC) to ensure training reflects current processes and inspection<br>expectations.</li>\n<li>Serve as a knowledge resource for complex TMF scenarios, regulatory expectations, and inspection readiness.</li>\n"},{"text":"About You:","content":"<div><strong>Education &amp; Experience:&nbsp;</strong></div>\n\n<li>Minimum 7-9 years of recent, related experience in TMF function within a Contract Research Organization, along with an Honour's Bachelor's degree</li>\n<li>Equivalent combination of education and experience may be considered.&nbsp;</li>\n<li>Strong working knowledge of ICH-GCP, 21 CFR Part 11, EU CTR, and other global regulatory requirements</li>\n<li>TMF Reference Model and risk-based TMF management principles</li>\n<li>Experience with inspection readiness activities (FDA, EMA, MHRA, etc) and TMF audits</li>\n<li>Procedural gap analysis and issue resolution in TMF contexts</li>\n<li>Experience with leading eTMF platforms (e.g., Veeva Vault, Wingspan)</li>\n<li>TMF governance, quality oversight, and inspection readiness</li>\n<li>Strong organizational, analytical, and problem-solving skills</li>\n<li>Excellent stakeholder management, communication, and client-facing skills</li>\n<li>Ability to work effectively in a global, matrixed environment</li>\n<li>Program-level or portfolio TMF oversight experience, including study alignment and risk management within a<br>sponsor or CRO environment</li>\n<li>Demonstrated ability to advise sponsors and cross-functional stakeholders on TMF strategy and risk management</li>\n<li>Certifications related to clinical research, quality, or regulatory compliance (e.g., SOCRA, ACRP, RAPS, TMF<br>certification) would be an asset</li>\n<li>Continuous improvement mindset and ability to provide study-level process guidance</li>\n"}],"salaryRange":{"currency":"GBP","interval":"per-year-salary","min":43000,"max":73500},"salaryDescription":"<div>+ Bonus&nbsp;</div>\n<div>&nbsp;</div>\n<div>Please note that the above range reflects the full spectrum of compensation for candidates located in the UK our Talent Acquisition team will be happy to discuss specific local compensation at time of interview.&nbsp;</div>","salaryDescriptionPlain":"+ Bonus \n \nPlease note that the above range reflects the full spectrum of compensation for candidates located in Germany - our Talent Acquisition team will be happy to discuss specific local compensation at time of interview. \n","text":"Sr. TMF Lead","country":"GB","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>\n<p><strong>ABOUT ALIMENTIV</strong></p>\n<p>Alimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.</p>\n<p>We operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.</p>\n<p>If you want to do meaningful work, build something real, and invest back in research that changes lives &mdash; we want to meet you.</p>\n<strong>THE OPPORTUNITY</strong></div>\n<div>&nbsp;</div>\n<div>The Sr. TMF Lead provides expert, study-facing TMF oversight for assigned studies and complex programs, ensuring TMF<br>quality, compliance, and continuous inspection readiness. Acting as a TMF subject matter expert (SME), the role aligns<br>sponsor-specific TMF requirements with CRO processes, applies risk-based TMF management practices, and leads TMF<br>execution from study start-up through close-out. The Sr. TMF Lead independently advises sponsors and internal stakeholders,<br>mentors TMF staff, and contributes subject matter expertise to TMF process and system improvements.&nbsp;</div>\n<div>&nbsp;</div>\n<div><strong>Positions available</strong>: 1; this opportunity is cross-listed in multiple locations. At this time, the position is open to those residing in Germany, Brazil, Poland, Hungary, and Romania.&nbsp;</div>\n<div><strong>Closing date</strong>: June 12th, 2026, or until successful candidate identified.&nbsp;</div>","descriptionBodyPlain":"ABOUT ALIMENTIV\nAlimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.\nWe operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.\nIf you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you.\nTHE OPPORTUNITY\n \nThe Sr. TMF Lead provides expert, study-facing TMF oversight for assigned studies and complex programs, ensuring TMF\nquality, compliance, and continuous inspection readiness. Acting as a TMF subject matter expert (SME), the role aligns\nsponsor-specific TMF requirements with CRO processes, applies risk-based TMF management practices, and leads TMF\nexecution from study start-up through close-out. The Sr. TMF Lead independently advises sponsors and internal stakeholders,\nmentors TMF staff, and contributes subject matter expertise to TMF process and system improvements. \n \nPositions available: 1; this opportunity is cross-listed in multiple locations. At this time, the position is open to those residing in Germany, Brazil, Poland, Hungary, and Romania. \nClosing date: June 12th, 2026, or until successful candidate identified. \n","hostedUrl":"https://jobs.lever.co/alimentiv-2/295cd4ae-342e-4316-a7ed-012cd49c4f7c","applyUrl":"https://jobs.lever.co/alimentiv-2/295cd4ae-342e-4316-a7ed-012cd49c4f7c/apply"},{"additionalPlain":"","additional":"<div><span data-teams=\"true\"><strong>Stay Alert to Recruitment Scams</strong><br>We have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.</span></div>","categories":{"commitment":"Full-time, Permanent","department":"Clinical Services","location":"London, Ontario","team":"Clinical Services - Statistics - Statistics & Programming","allLocations":["London, Ontario","Toronto, Ontario","Vancouver, British Columbia","Calgary, Alberta","Winnipeg, Manitoba","Montreal, Quebec","Ottawa, Ontario"]},"createdAt":1776126888530,"descriptionPlain":"Responsible for the application of biostatistical methods to support clinical trials and data management, including statistical planning, design, analysis, and reporting   throughout the project life cycle in accordance with project, organizational and regulatory standards.  Act as   subject matter expert, providing statistical support to project teams, quality/study auditors, and external stakeholders. Participate in the promotion of Alimentiv as a global research organization, by contributing to   the development, publishing, and reporting of project data. Please note we are hiring for multiple positions at this time. \n","description":"<div>Responsible for the application of biostatistical methods to support clinical trials and data management, including statistical planning, design, analysis, and reporting throughout the project life cycle in accordance with project, organizational and regulatory standards.&nbsp; Act as subject matter expert, providing statistical support to project teams, quality/study auditors, and external stakeholders. Participate in the promotion of Alimentiv as a global research organization, by contributing to the development, publishing, and reporting of project data. Please note we are hiring for multiple positions at this time.</div>","id":"de31c7c3-a98d-46f6-bd2b-7c0bcd9d706f","lists":[{"text":"Analysis Services","content":"\n<li>Carry out statistical analyses and provide direction to programmers, using standard software packages to interpret and translate results within a statistical framework into biomedical terms and prepare statistical data results for inclusion in reports and research papers that meet trial, organizational and regulatory best practices, and standards.</li>\n"},{"text":"Academic Research Support","content":"\n<li>Working in conjunction with the Director of Academic Research, convert and present new and novel biometrical trial technologies, processes and findings into publishable and promotable scientific processes and results.</li>\n"},{"text":"Project Support ","content":"\n<li>Provide statistical expertise and guidance based on established methodologies throughout the project life cycle in the areas of study policies, protocols, implementation timelines and processes, data interpretation and publication of results.</li>\n<li>Work with data management team to ensure data captured incorporates and corresponds to project protocols and requirements.<strong>&nbsp;</strong>&nbsp;</li>\n"},{"text":"Statistical Analysis/Data Collection Planning ","content":"\n<li>Prepare statistical analysis plan and oversee project data collection, management, and analysis with input from the project teams that incorporates the type of information collected, sample size, randomization procedures, table and listing shells, project statistical policies, protocols, and methodology to be used to appropriately translate scientific questions into statistical hypotheses.</li>\n"},{"text":"Study Report Support","content":"\n<li>Assist medical director(s) and/or technical writers by preparing statistical section of study report, publications and/or presentations ensuring statistical analyses adheres to trial, sponsor, organizational and regulatory requirements, and best practices.</li>\n"},{"text":"Qualifications","content":"\n<li>A minimum of a Bachelor's or Master's degree and a professional designation + 1-3 years of related experience.</li>\n<li>Experience in the industry, or in an academic setting is preferred.</li>\n<li>Very strong communication skills is a must.</li>\n\n<div>&nbsp;</div>"},{"text":"Working Conditions","content":"\n<li>Home-based.</li>\n"}],"salaryRange":{"min":78000,"max":130000,"currency":"CAD","interval":"per-year-salary"},"salaryDescription":"<div>+bonus</div>","salaryDescriptionPlain":"+bonus\n","text":"Statistician","country":"CA","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>Responsible for the application of biostatistical methods to support clinical trials and data management, including statistical planning, design, analysis, and reporting throughout the project life cycle in accordance with project, organizational and regulatory standards.&nbsp; Act as subject matter expert, providing statistical support to project teams, quality/study auditors, and external stakeholders. Participate in the promotion of Alimentiv as a global research organization, by contributing to the development, publishing, and reporting of project data. Please note we are hiring for multiple positions at this time.</div>","descriptionBodyPlain":"Responsible for the application of biostatistical methods to support clinical trials and data management, including statistical planning, design, analysis, and reporting   throughout the project life cycle in accordance with project, organizational and regulatory standards.  Act as   subject matter expert, providing statistical support to project teams, quality/study auditors, and external stakeholders. Participate in the promotion of Alimentiv as a global research organization, by contributing to   the development, publishing, and reporting of project data. Please note we are hiring for multiple positions at this time. \n","hostedUrl":"https://jobs.lever.co/alimentiv-2/de31c7c3-a98d-46f6-bd2b-7c0bcd9d706f","applyUrl":"https://jobs.lever.co/alimentiv-2/de31c7c3-a98d-46f6-bd2b-7c0bcd9d706f/apply"},{"additionalPlain":"","additional":"<div><span data-teams=\"true\"><strong>Stay Alert to Recruitment Scams</strong><br>We have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.</span></div>","categories":{"commitment":"Full-time, Permanent","department":"Clinical Services","location":"Boston, Massachusetts","team":"Clinical Services - Statistics - Statistics & Programming","allLocations":["Boston, Massachusetts","Philadelphia, Pennsylvania","Raleigh-Durham, North Carolina","Houston, Texas","Austin, Texas"]},"createdAt":1776127234703,"descriptionPlain":"Responsible for   the application of biostatistical methods to support clinical trials and data   management, including statistical planning, design, analysis, and reporting   throughout the project life cycle in accordance with project, organizational   and regulatory standards.  Act as   subject matter expert, providing statistical support to project teams, quality/study auditors, and external stakeholders. Participate in the   promotion of Alimentiv as a global research organization, by contributing to   the development, publishing, and reporting of project data.\n","description":"<div>Responsible for the application of biostatistical methods to support clinical trials and data management, including statistical planning, design, analysis, and reporting throughout the project life cycle in accordance with project, organizational and regulatory standards.&nbsp; Act as subject matter expert, providing statistical support to project teams, quality/study auditors, and external stakeholders. Participate in the promotion of Alimentiv as a global research organization, by contributing to the development, publishing, and reporting of project data.</div>","id":"fab5cdca-0cb4-4ed3-a68c-520003608264","lists":[{"text":"Analysis Services","content":"\n<li>Carry out statistical analyses and provide direction to programmers, using standard software packages to interpret and translate results within a statistical framework into biomedical terms and prepare statistical data results for inclusion in reports and research papers that meet trial, organizational and regulatory best practices, and standards.</li>\n"},{"text":"Academic Research Support","content":"\n<li>Working in conjunction with the Director of Academic Research, convert and present new and novel biometrical trial technologies, processes and findings into publishable and promotable scientific processes and results.</li>\n"},{"text":"Project Support ","content":"\n<li>Provide statistical expertise and guidance based on established methodologies throughout the project life cycle in the areas of study policies, protocols, implementation timelines and processes, data interpretation and publication of results. Work with data management team to ensure data captured incorporates and corresponds to project protocols and requirements.<strong>&nbsp;</strong>&nbsp;</li>\n"},{"text":"Statistical Analysis/Data Collection Planning ","content":"\n<li>Prepare statistical analysis plan and oversee project data collection, management, and analysis with input from the project teams that incorporates the type of information collected, sample size, randomization procedures, table and listing shells, project statistical policies, protocols, and methodology to be used to appropriately translate scientific questions into statistical hypotheses.</li>\n"},{"text":"Study Report Support","content":"\n<li>Assist medical director(s) and/or technical writers by preparing statistical section of study report, publications and/or presentations ensuring statistical analyses adheres to trial, sponsor, organizational and regulatory requirements, and best practices.</li>\n"},{"text":"Qualifications","content":"<div>\n\n<li>The successful candidate should hold a minimum of an undergraduate degree with professional certifications and 4-6 years of professional experience. A Masters' degree in Statistics or Biostatistics specialty is preferred.</li>\n<li>PhD with experience in research is a strong asset.</li>\n<li>Experience in the industry, or in an academic setting is preferred.</li>\n<li>Very strong communication skills is a must.</li>\n\n</div>"}],"salaryRange":{"min":86000,"max":143000,"currency":"USD","interval":"per-year-salary"},"text":"Statistician","country":"US","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>Responsible for the application of biostatistical methods to support clinical trials and data management, including statistical planning, design, analysis, and reporting throughout the project life cycle in accordance with project, organizational and regulatory standards.&nbsp; Act as subject matter expert, providing statistical support to project teams, quality/study auditors, and external stakeholders. Participate in the promotion of Alimentiv as a global research organization, by contributing to the development, publishing, and reporting of project data.</div>","descriptionBodyPlain":"Responsible for   the application of biostatistical methods to support clinical trials and data   management, including statistical planning, design, analysis, and reporting   throughout the project life cycle in accordance with project, organizational   and regulatory standards.  Act as   subject matter expert, providing statistical support to project teams, quality/study auditors, and external stakeholders. Participate in the   promotion of Alimentiv as a global research organization, by contributing to   the development, publishing, and reporting of project data.\n","hostedUrl":"https://jobs.lever.co/alimentiv-2/fab5cdca-0cb4-4ed3-a68c-520003608264","applyUrl":"https://jobs.lever.co/alimentiv-2/fab5cdca-0cb4-4ed3-a68c-520003608264/apply"},{"additionalPlain":"Stay Alert to Recruitment Scams\nWe have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.\n","additional":"<div><span data-teams=\"true\"><strong>Stay Alert to Recruitment Scams</strong><br>We have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.</span></div>","categories":{"commitment":"Full-time, Permanent","department":"Corporate Operations","location":"London, Ontario","team":"Technology and Innovation","allLocations":["London, Ontario"]},"createdAt":1779802324393,"descriptionPlain":"The Team Lead, Product Support leads the Product Support team responsible for delivering reliable product support for Alimentiv’s clinical imaging ecosystem. The role drives issue resolution, escalation management, and continuous process improvement while coordinating across multiple customer facing support functions to ensure a consistent and unified customer experience. Acting as a player/coach, the Team Lead participates directly in day-to-day support activities, complex incidents, and high priority escalations to model best practices and accelerate resolution.\n","description":"<div>The Team Lead, Product Support leads the Product Support team responsible for delivering reliable product support for Alimentiv’s clinical imaging ecosystem. The role drives issue resolution, escalation management, and continuous process improvement while coordinating across multiple customer facing support functions to ensure a consistent and unified customer experience. Acting as a player/coach, the Team Lead participates directly in day-to-day support activities, complex incidents, and high priority escalations to model best practices and accelerate resolution.</div>","id":"8f74188d-85d9-42c9-aea3-2a36c9178ba6","lists":[{"text":"Team Leadership & Support Operations (25-30%)","content":"<div>\n<ul type=\"disc\">\n<li>Lead, grow, and mentor Product Support Specialists, setting clear expectations for ownership, accountability, and customer focus.</li>\n<li>Establish team priorities, operating norms, and performance goals, and manage workload, escalation flow, and on call coverage to ensure timely and effective issue resolution.</li>\n<li>Act as a player/coach during complex cases and critical incidents, providing hands on guidance and modeling effective troubleshooting and communication practices.</li>\n<li>Coordinate day-to-day support activities across customer facing support functions to drive consistency in processes, messaging, and customer experience.</li>\n\n</ul></div>"},{"text":"Support Strategy & Process Improvement (15-20%)","content":"<div>\n<ul type=\"disc\">\n<li>Define, implement, and continuously improve support workflows, escalation paths, and knowledge management practices.</li>\n<li>Establish and monitor support metrics, analyze trends, and drive improvements to resolution time, quality, and customer satisfaction.</li>\n<li>Identify recurring issues and systemic gaps, and coordinate with cross functional partners to drive durable solutions and reduce repeat incidents.</li>\n<li>Improve support tooling, documentation, and self-service capabilities to increase efficiency and reduce reliance on engineering teams.</li>\n\n</ul></div>"},{"text":"Direct Technical Support & Issue Resolution (30-35%)","content":"<div>\n<ul type=\"disc\">\n<li>Actively handle support cases alongside the team, providing hands on investigation and resolution across a range of issue types and severities.</li>\n<li>Serve as an escalation point for complex or high impact issues, leading deeper technical analysis and coordinating response as needed.&nbsp;</li>\n\n</ul></div>"},{"text":"Cross Functional Coordination & Stakeholder Communication (10-15%)","content":"<div>\n<ul type=\"disc\">\n<li>Lead coordination across customer facing support functions to ensure consistent processes, messaging, and customer experience.</li>\n<li>Communicate support trends, risks, and systemic issues clearly to stakeholders, enabling informed prioritization and decision making.</li>\n\n</ul></div>"},{"text":"QUALIFICATIONS","content":"<div>\n<p><strong>Required:</strong></p>\n<ul type=\"disc\">\n<li>3+ years of experience in technical product support or customer facing technical roles, including hands on issue investigation and resolution.</li>\n<li>Demonstrated experience leading, mentoring, or guiding support team members while remaining actively engaged in day-to-day support work.</li>\n<li>Strong troubleshooting skills across software and hardware-based systems, with the ability to diagnose issues, identify root causes, and drive resolution.</li>\n<li>Experience coordinating support activities across teams to deliver a consistent and effective customer support experience.</li>\n<li>Ability to establish and improve support processes, metrics, and documentation to increase efficiency and reduce repeat issues.</li>\n<li>Clear, concise communication skills, with the ability to translate technical issues into actionable insights for diverse audiences.</li>\n\n<p><strong>Preferred:</strong></p>\n<ul type=\"disc\">\n<li>5+ years of experience in technical support, service operations, or related roles with increasing responsibility.</li>\n<li>Experience supporting products in regulated, clinical, or healthcare adjacent environments.</li>\n<li>Familiarity with ITSM and issue tracking platforms such as ServiceNow and Jira.</li>\n\nExposure to knowledge base management, self-service tooling, or support automation</ul></ul></div>"}],"salaryRange":{"min":69000,"max":115500,"currency":"CAD","interval":"per-year-salary"},"salaryDescription":"<div>\n<p><strong>Extended Health Benefits</strong>:</p>\n<ul type=\"disc\">\n<li>Health</li>\n<li>Drug</li>\n<li>Dental</li>\n<li>Vision</li>\n<li>Out of Province/Country Emergency Health</li>\n</ul>\n<p><strong>Insurance &amp; Protection</strong>:</p>\n<ul type=\"disc\">\n<li>Accidental Death &amp; Dismemberment (AD&amp;D)</li>\n<li>Life Insurance for you and your family members</li>\n<li>Short- and Long-Term Disability</li>\n</ul>\n<p><strong>Retirement Savings</strong>:</p>\n<ul type=\"disc\">\n<li>Group Retirement Savings Plan (7% employer match with 5% employee contribution)</li>\n</ul>\n<p><strong>Wellness &amp; Lifestyle Perks</strong>:</p>\n<ul type=\"disc\">\n<li>Education Reimbursement of up to $1,050 CAD (or local equivalent) annually for eligible expenses</li>\n<li>Summer Hours Program</li>\n<li>Work Abroad Program – enjoy up to 4 weeks per year of remote work outside your home region</li>\n</ul>\n<p><strong>Performance &amp; Recognition</strong>:</p>\n<ul type=\"disc\">\n<li>Short-Term Incentive Program of up to 8% of salary</li>\n</ul>\n</div>","salaryDescriptionPlain":"Extended Health Benefits:\nHealth\nDrug\nDental\nVision\nOut of Province/Country Emergency Health\nInsurance & Protection:\nAccidental Death & Dismemberment (AD&D)\nLife Insurance for you and your family members\nShort- and Long-Term Disability\nRetirement Savings:\nGroup Retirement Savings Plan (7% employer match with 5% employee contribution)\nWellness & Lifestyle Perks:\nEducation Reimbursement of up to $1,050 CAD (or local equivalent) annually for eligible expenses\nSummer Hours Program\nWork Abroad Program – enjoy up to 4 weeks per year of remote work outside your home region\nPerformance & Recognition:\nShort-Term Incentive Program of up to 8% of salary\n","text":"Team Lead, Product Support","country":"CA","workplaceType":"hybrid","opening":"","openingPlain":"","descriptionBody":"<div>The Team Lead, Product Support leads the Product Support team responsible for delivering reliable product support for Alimentiv&rsquo;s clinical imaging ecosystem. The role drives issue resolution, escalation management, and continuous process improvement while coordinating across multiple customer facing support functions to ensure a consistent and unified customer experience. Acting as a player/coach, the Team Lead participates directly in day-to-day support activities, complex incidents, and high priority escalations to model best practices and accelerate resolution.</div>","descriptionBodyPlain":"The Team Lead, Product Support leads the Product Support team responsible for delivering reliable product support for Alimentiv’s clinical imaging ecosystem. The role drives issue resolution, escalation management, and continuous process improvement while coordinating across multiple customer facing support functions to ensure a consistent and unified customer experience. Acting as a player/coach, the Team Lead participates directly in day-to-day support activities, complex incidents, and high priority escalations to model best practices and accelerate resolution.\n","hostedUrl":"https://jobs.lever.co/alimentiv-2/8f74188d-85d9-42c9-aea3-2a36c9178ba6","applyUrl":"https://jobs.lever.co/alimentiv-2/8f74188d-85d9-42c9-aea3-2a36c9178ba6/apply"},{"additional":"","additionalPlain":"","categories":{"commitment":"Full-time, Permanent","department":"Clinical Services","location":"Warsaw","team":"Clinical Services - TMF Operations","allLocations":["Warsaw","Budapest","London","Bucharest","Toronto, Ontario","London, Ontario"]},"createdAt":1779393967916,"descriptionPlain":"Job Title: TMF Associate\n\nJob Location: Toronto, ON\n\nJob Salary: $50,000 - $84,000 CAD\n\nEmployment Type: Full time, Limited Term (18-month contract)\n\nJob Reports To: Manager, TMF Operations\n\nDepartment/Unit Name: TMF Operations\n\n\nJob Summary:\nResponsible for the management of the Trial Master File (TMF) content and associated processes during the study life cycle from study set up to transfer/archiving. Work in partnership with study teams during periodic file reviews and audits to address findings related to the TMF. Manage access and organization of the controlled electronic file repository, in line with the defined file structure and access management framework. Work proactively and successfully within a cross-functional team. Communicate and promote department and company goals and practices. Interact with stakeholders in a way that fosters a positive working atmosphere and encompasses a professional and helpful attitude. Time allocated may be adjusted based on need. \n","description":"<div><strong>Job Title:</strong>&nbsp;TMF Associate</div>\n<div>&nbsp;</div>\n<div><strong>Employment Type:&nbsp;</strong>Full time, Permanent</div>\n<div>&nbsp;</div>\n<div><strong>Job Reports To</strong>:&nbsp;Manager, TMF Operations</div>\n<div>&nbsp;</div>\n<div><strong>Department/Unit Name</strong>: TMF Operations</div>\n<div>&nbsp;</div>\n<div>&nbsp;</div>\n<div><strong>Job Summary:</strong></div>\n<div>Responsible for the management of the Trial Master File (TMF) content and associated processes during the study life cycle from study set&nbsp;up to transfer/archiving. Work in partnership with study teams during periodic file reviews and audits to address findings related to the&nbsp;TMF. Manage access and organization of the controlled electronic file repository, in line with the defined file structure and access&nbsp;management framework. Work proactively and successfully within a cross-functional team. Communicate and promote department and&nbsp;company goals and practices. Interact with stakeholders in a way that fosters a positive working atmosphere and encompasses a&nbsp;professional and helpful attitude. Time allocated may be adjusted based on need.&nbsp;</div>\n<div>&nbsp;</div>\n<div>\n<div><strong>Positions Available</strong>: 2; Note this position is cross-listed in multiple countries.</div>\n</div>","id":"e6eaa373-6142-469c-b590-fbd1c6025423","lists":[{"text":"Service Delivery","content":"\n<li>Serve&nbsp;as the primary TMF contact for assigned studies.</li>\n<li>Ensure TMF is complete&nbsp;and “inspection ready” throughout study lifecycle and documents are filed contemporaneously.</li>\n<li>Work with Team Lead&nbsp;to create study specific TMF management and oversight documents (e.g., File Index, Expected Document Lists and TMF Management Plan) in alignment with study.</li>\n<li>Develop and maintain&nbsp;study-specific work instructions, as needed.</li>\n<li>Utilize&nbsp;organization skills to maintain a quality control schedule and perform periodic inventories of study TMF to ensure completeness.</li>\n<li>Review and&nbsp;communicate out-of-scope and/or incomplete documents to study teams; escalating as needed.</li>\n<li>Reconcile expected&nbsp;document lists based on study events and milestones.</li>\n<li>Prioritize&nbsp;and resolve TMF help desk tickets; may include triaging activities.</li>\n<li>Provide study specific&nbsp;TMF training to internal and/or external stakeholders, as needed.</li>\n<li>Process and&nbsp;review documents, following applicable scanning and best practices and best&nbsp;practices, and applying ALCOA principles appropriately.</li>\n<li>File&nbsp;and retrieve TMF documents in a timely manner.</li>\n"},{"text":"Department Support","content":"\n<li>Complete routine administrative tasks in a timely manner (e.g., timesheets, metrics).</li>\n<li>Participate in discussions, decisions and sharing of knowledge in department meetings, periodic presentations, and smaller working groups.</li>\n<li>Seek opportunities to assist in the development, implementation and maintenance of internal systems (e.g., databases used to manage records).</li>\n<li>Provide mentorship and training to junior level staff.</li>\n<li>Propose suggestions and work on the development and maintenance of department quality system documents to improve efficiencies.</li>\n"},{"text":"Qualifications","content":"\n<li>The successful candidate will possess a college diploma/degree and 1-3 years of relative related experience or on going training. They will have an understanding of TMF organization, implementation, and archival including relevant regulations and guidance to assure quality and integrity of TMFs. Have the ability to incorporate the principles of ALCOA in relation to TMF oversight.&nbsp; Utilize skills in time management and problem-solving.&nbsp; Identify challenges and problems and take the initiative to identify solutions.&nbsp; Demonstrated computer literacy, proven functional knowledge of Microsoft packages and potential to develop.</li>\n"},{"text":"Working Conditions","content":"\n<li>- Home based, with the ability to go into office occasionally if needed.&nbsp;</li>\n<li>*<em>Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle. Requests can be directed to&nbsp;<a rel=\"noopener noreferrer\" href=\"mailto:recruitment@alimentiv.com\" class=\"postings-link\">recruitment@alimentiv.com</a></em></li>\n"},{"text":"Warning","content":"\n<li>PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.</li>\n"}],"text":"TMF Associate","country":"PL","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div><strong>Job Title:</strong>&nbsp;TMF Associate</div>\n<div>&nbsp;</div>\n<div><strong>Employment Type:&nbsp;</strong>Full time, Permanent</div>\n<div>&nbsp;</div>\n<div><strong>Job Reports To</strong>:&nbsp;Manager, TMF Operations</div>\n<div>&nbsp;</div>\n<div><strong>Department/Unit Name</strong>: TMF Operations</div>\n<div>&nbsp;</div>\n<div>&nbsp;</div>\n<div><strong>Job Summary:</strong></div>\n<div>Responsible for the management of the Trial Master File (TMF) content and associated processes during the study life cycle from study set&nbsp;up to transfer/archiving. Work in partnership with study teams during periodic file reviews and audits to address findings related to the&nbsp;TMF. Manage access and organization of the controlled electronic file repository, in line with the defined file structure and access&nbsp;management framework. Work proactively and successfully within a cross-functional team. Communicate and promote department and&nbsp;company goals and practices. Interact with stakeholders in a way that fosters a positive working atmosphere and encompasses a&nbsp;professional and helpful attitude. Time allocated may be adjusted based on need.&nbsp;</div>\n<div>&nbsp;</div>\n<div>\n<div><strong>Positions Available</strong>: 2; Note this position is cross-listed in multiple countries.</div>\n</div>","descriptionBodyPlain":"Job Title: TMF Associate\n\nJob Location: Toronto, ON\n\nJob Salary: $50,000 - $84,000 CAD\n\nEmployment Type: Full time, Limited Term (18-month contract)\n\nJob Reports To: Manager, TMF Operations\n\nDepartment/Unit Name: TMF Operations\n\n\nJob Summary:\nResponsible for the management of the Trial Master File (TMF) content and associated processes during the study life cycle from study set up to transfer/archiving. Work in partnership with study teams during periodic file reviews and audits to address findings related to the TMF. Manage access and organization of the controlled electronic file repository, in line with the defined file structure and access management framework. Work proactively and successfully within a cross-functional team. Communicate and promote department and company goals and practices. Interact with stakeholders in a way that fosters a positive working atmosphere and encompasses a professional and helpful attitude. Time allocated may be adjusted based on need. \n","hostedUrl":"https://jobs.lever.co/alimentiv-2/e6eaa373-6142-469c-b590-fbd1c6025423","applyUrl":"https://jobs.lever.co/alimentiv-2/e6eaa373-6142-469c-b590-fbd1c6025423/apply"},{"additionalPlain":"Stay Alert to Recruitment Scams\nWe have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.\n","additional":"<div><span data-teams=\"true\"><span data-teams=\"true\"><strong>Stay Alert to Recruitment Scams</strong><br>We have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.</span></span></div>","categories":{"commitment":"Full-time, Permanent","department":"Corporate Operations","location":"Toronto, Ontario","team":"Technology and Innovation","allLocations":["Toronto, Ontario"]},"createdAt":1780284945158,"descriptionPlain":"The AI Enablement Specialist supports the adoption of artificial intelligence tools across Alimentiv by providing structured training, practical guidance, and implementation support to staff at all levels. This role serves as the primary liaison between technology teams and end users, translating technical capabilities into accessible resources and workflows. Operating at the intersection of technology and people, this role uses accessible AI platforms and no-code tools to prototype and demonstrate solutions — not to develop or maintain production systems. Reporting to the VP, IT Operations, Security & Workplace AI, the Specialist contributes directly to Alimentiv's AI governance and organizational capability-building objectives.\n","description":"<div>The AI Enablement Specialist supports the adoption of artificial intelligence tools across Alimentiv by providing structured training, practical guidance, and implementation support to staff at all levels. This role serves as the primary liaison between technology teams and end users, translating technical capabilities into accessible resources and workflows. Operating at the intersection of technology and people, this role uses accessible AI platforms and no-code tools to prototype and demonstrate solutions — not to develop or maintain production systems. Reporting to the VP, IT Operations, Security &amp; Workplace AI, the Specialist contributes directly to Alimentiv's AI governance and organizational capability-building objectives.</div>","id":"0b010fe1-60be-4c9d-9b73-8b0a6e4c735a","lists":[{"text":"AI Research (30%)","content":"<div>\n<ul type=\"disc\">\n<li>Conducts needs assessments across departments to identify opportunities where AI tools can improve operational efficiency or research outcomes.</li>\n<li>Monitors emerging AI technologies and evaluates their relevance to Alimentiv's operational context.</li>\n<li>Develops roadmaps that align AI opportunities with organizational priorities and realistic implementation timelines.</li>\n<li>Synthesizes industry trends into actionable recommendations tailored to Alimentiv's business environment.</li>\n<li>Evaluates AI platforms and tools against defined use cases, documenting findings in structured assessments.</li>\n<li>Develops lightweight solution prototypes to validate feasibility before full implementation is pursued.</li>\n<li>Prepares business cases that articulate the value and feasibility of proposed AI initiatives for non-technical stakeholders.</li>\n\n</ul></div>"},{"text":"User Enablement (35%)","content":"<div>\n<ul type=\"disc\">\n<li>Designs and delivers structured training programs that build AI proficiency across diverse teams and skill levels.</li>\n<li>Produces plain-language reference materials, guides, and job aids that support independent tool use.</li>\n<li>Facilitates workshops and demonstrations that connect AI capabilities to team-specific workflows.</li>\n<li>Provides hands-on support during tool rollouts to accelerate user proficiency and resolve adoption barriers.</li>\n<li>Identifies and addresses adoption obstacles through targeted follow-up and adjusted delivery approaches.</li>\n<li>Establishes communities of practice to enable peer learning and sustained engagement with AI tools.</li>\n<li>Monitors usage data and initiates proactive outreach where additional training or support is indicated</li>\n\n</ul></div>"},{"text":"Solution Development (25%)","content":"<div>\n<ul type=\"disc\">\n<li>Designs and builds proof-of-concept AI solutions that demonstrate practical value to specific business functions.</li>\n<li>Develops working prototypes using no-code and low-code AI platforms to illustrate how AI can be applied to real operational challenges.</li>\n<li>Presents and demonstrates prototype solutions to stakeholders, translating outputs into clear business value.</li>\n<li>Builds demonstrations and prototypes using no-code and low-code AI platforms; production development and system integration remain the responsibility of technical IT and development teams.</li>\n<li>Gathers departmental requirements and communicates them to technical teams in plain language.</li>\n<li>Coordinates cross-functional stakeholders to ensure AI tool configurations align with operational workflows.</li>\n<li>Develops standard operating procedures that integrate AI tools into established team workflows.</li>\n\n</ul></div>"},{"text":"Performance Measurement (10%)","content":"<div>\n<ul type=\"disc\">\n<li>Establishes success metrics that capture both adoption rates and measurable business impact.</li>\n<li>Analyzes usage and performance data to assess initiative effectiveness and identify areas for improvement.</li>\n<li>Prepares reports that communicate AI initiative outcomes clearly to leadership audiences.</li>\n<li>Conducts post-implementation reviews to capture lessons learned and apply findings to future rollouts.</li>\n\n</ul></div>"},{"text":"QUALIFICATIONS","content":"<div>\n\n<li data-section-id=\"f0q5ck\" data-start=\"59\" data-end=\"93\">3+ years of related experience</li>\n<li data-section-id=\"rixlfd\" data-start=\"94\" data-end=\"125\">(Honours) Bachelor’s degree</li>\n<li data-section-id=\"1480n0e\" data-start=\"126\" data-end=\"168\">Fluent in English (verbal and written)</li>\n<li data-section-id=\"1qolcbn\" data-start=\"170\" data-end=\"282\">Ability to communicate complex or technical concepts clearly to non-technical audiences (verbal and written)</li>\n<li data-section-id=\"fkl6cf\" data-start=\"283\" data-end=\"430\">Demonstrated ability to build effective working relationships across all organizational levels, including frontline staff and senior leadership</li>\n<li data-section-id=\"1hyz8pg\" data-start=\"431\" data-end=\"515\">Experience designing and delivering training programs for diverse adult learners</li>\n<li data-section-id=\"w4cxhj\" data-start=\"516\" data-end=\"596\">Knowledge of change management principles and technology adoption frameworks</li>\n<li data-section-id=\"yc4s00\" data-start=\"597\" data-end=\"692\">Ability to identify underlying user needs and develop practical, targeted support solutions</li>\n<li data-section-id=\"1vp3w2\" data-start=\"693\" data-end=\"796\">Experience producing user documentation, guides, and job aids that reduce barriers to tool adoption</li>\n<li data-section-id=\"1r1mw0u\" data-start=\"798\" data-end=\"986\">Proficiency with no-code and low-code platforms (e.g., Microsoft Copilot Studio, Power Automate, Claude.ai) to configure and demonstrate AI-powered workflows without custom development</li>\n<li data-section-id=\"hi4srh\" data-start=\"987\" data-end=\"1108\">Ability to develop functional proof-of-concept solutions demonstrating AI applicability to specific business problems</li>\n<li data-section-id=\"aessyu\" data-start=\"1109\" data-end=\"1219\">Familiarity with prompt engineering and understanding of large language model capabilities and limitations</li>\n<li data-section-id=\"l8cq7g\" data-start=\"1220\" data-end=\"1372\">Ability to define and communicate the boundary between enablement-level prototyping and production development requiring IT or developer involvement</li>\n<li data-section-id=\"1h5z84g\" data-start=\"1374\" data-end=\"1481\">Strong cross-functional collaboration skills and ability to align stakeholders around shared objectives</li>\n<li data-section-id=\"1bmvppb\" data-start=\"1482\" data-end=\"1568\">Ability to interpret adoption metrics and usage data to prioritize support efforts</li>\n<li data-section-id=\"t506c4\" data-start=\"1569\" data-end=\"1680\">Working knowledge of AI tools sufficient to guide end-user adoption (deep technical expertise not required)</li>\n<li data-section-id=\"9md780\" data-start=\"1681\" data-end=\"1774\">Familiarity with data privacy principles and responsible AI use in regulated environments</li>\n<li data-section-id=\"14bi1bw\" data-start=\"1776\" data-end=\"1846\" data-is-last-node=\"\">Experience in clinical research or healthcare is considered an asset</li>\n\n</div>"}],"salaryRange":{"min":51000,"max":84500,"currency":"CAD","interval":"per-year-salary"},"salaryDescription":"<p><strong>Extended Health Benefits</strong>:</p>\n<ul type=\"disc\">\n<li>Health</li>\n<li>Drug</li>\n<li>Dental</li>\n<li>Vision</li>\n<li>Out of Province/Country Emergency Health</li>\n</ul>\n<p><strong>Insurance &amp; Protection</strong>:</p>\n<ul type=\"disc\">\n<li>Accidental Death &amp; Dismemberment (AD&amp;D)</li>\n<li>Life Insurance for you and your family members</li>\n<li>Short- and Long-Term Disability</li>\n</ul>\n<p><strong>Retirement Savings</strong>:</p>\n<ul type=\"disc\">\n<li>Group Retirement Savings Plan (7% employer match with 5% employee contribution)</li>\n</ul>\n<p><strong>Wellness &amp; Lifestyle Perks</strong>:</p>\n<ul type=\"disc\">\n<li>Education Reimbursement of up to $1,050 CAD (or local equivalent) annually for eligible expenses</li>\n<li>Summer Hours Program</li>\n<li>Work Abroad Program – enjoy up to 4 weeks per year of remote work outside your home region</li>\n</ul>\n<p><strong>Performance &amp; Recognition</strong>:</p>\n<ul type=\"disc\">\n<li>Short-Term Incentive Program of up to 6% of salary</li>\n</ul>","salaryDescriptionPlain":"Extended Health Benefits:\nHealth\nDrug\nDental\nVision\nOut of Province/Country Emergency Health\nInsurance & Protection:\nAccidental Death & Dismemberment (AD&D)\nLife Insurance for you and your family members\nShort- and Long-Term Disability\nRetirement Savings:\nGroup Retirement Savings Plan (7% employer match with 5% employee contribution)\nWellness & Lifestyle Perks:\nEducation Reimbursement of up to $1,050 CAD (or local equivalent) annually for eligible expenses\nSummer Hours Program\nWork Abroad Program – enjoy up to 4 weeks per year of remote work outside your home region\nPerformance & Recognition:\nShort-Term Incentive Program of up to 6% of salary\n","text":"Workplace AI Business Analyst Specialist","country":"CA","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>The AI Enablement Specialist supports the adoption of artificial intelligence tools across Alimentiv by providing structured training, practical guidance, and implementation support to staff at all levels. This role serves as the primary liaison between technology teams and end users, translating technical capabilities into accessible resources and workflows. Operating at the intersection of technology and people, this role uses accessible AI platforms and no-code tools to prototype and demonstrate solutions &mdash; not to develop or maintain production systems. Reporting to the VP, IT Operations, Security &amp; Workplace AI, the Specialist contributes directly to Alimentiv's AI governance and organizational capability-building objectives.</div>","descriptionBodyPlain":"The AI Enablement Specialist supports the adoption of artificial intelligence tools across Alimentiv by providing structured training, practical guidance, and implementation support to staff at all levels. This role serves as the primary liaison between technology teams and end users, translating technical capabilities into accessible resources and workflows. Operating at the intersection of technology and people, this role uses accessible AI platforms and no-code tools to prototype and demonstrate solutions — not to develop or maintain production systems. Reporting to the VP, IT Operations, Security & Workplace AI, the Specialist contributes directly to Alimentiv's AI governance and organizational capability-building objectives.\n","hostedUrl":"https://jobs.lever.co/alimentiv-2/0b010fe1-60be-4c9d-9b73-8b0a6e4c735a","applyUrl":"https://jobs.lever.co/alimentiv-2/0b010fe1-60be-4c9d-9b73-8b0a6e4c735a/apply"},{"additionalPlain":"","additional":"<div><span data-teams=\"true\"><span data-teams=\"true\"><strong>Stay Alert to Recruitment Scams</strong><br>We have been made aware of individuals posing as our recruiters and contacting candidates with fraudulent opportunities. Our hiring process always includes direct engagement with a recruiter or hiring manager, and we will never ask for sensitive personal information early in the process. Official communication will only come from our company email domains. If something doesn’t feel right, we encourage you to verify before responding.</span></span></div>","categories":{"commitment":"Full-time, Permanent","department":"Corporate Operations","location":"Toronto, Ontario","team":"Technology and Innovation","allLocations":["Toronto, Ontario"]},"createdAt":1774964781493,"descriptionPlain":"","description":"<div>The AI Enablement Specialist supports the adoption of artificial intelligence tools across Alimentiv by providing structured training, practical guidance, and implementation support to staff at all levels. This role serves as the primary liaison between technology teams and end users, translating technical capabilities into accessible resources and workflows. Operating at the intersection of technology and people, this role uses accessible AI platforms and no-code tools to prototype and demonstrate solutions — not to develop or maintain production systems. Reporting to the VP, IT Operations, Security &amp; Workplace AI, the Specialist contributes directly to Alimentiv's AI governance and organizational capability-building objectives.</div>","id":"e14bcebb-519d-493a-913f-ad61c91faa6f","lists":[{"text":"AI Research (30%)","content":"<div>\n<ul type=\"disc\">\n<li>Conducts needs assessments across departments to identify opportunities where AI tools can improve operational efficiency or research outcomes.</li>\n<li>Monitors emerging AI technologies and evaluates their relevance to Alimentiv's operational context.</li>\n<li>Develops roadmaps that align AI opportunities with organizational priorities and realistic implementation timelines.</li>\n<li>Synthesizes industry trends into actionable recommendations tailored to Alimentiv's business environment.</li>\n<li>Evaluates AI platforms and tools against defined use cases, documenting findings in structured assessments.</li>\n<li>Develops lightweight solution prototypes to validate feasibility before full implementation is pursued.</li>\n<li>Prepares business cases that articulate the value and feasibility of proposed AI initiatives for non-technical stakeholders.</li>\n\n</ul></div>"},{"text":"User Enablement (35%)","content":"<div>\n<ul type=\"disc\">\n<li>Designs and delivers structured training programs that build AI proficiency across diverse teams and skill levels.</li>\n<li>Produces plain-language reference materials, guides, and job aids that support independent tool use.</li>\n<li>Facilitates workshops and demonstrations that connect AI capabilities to team-specific workflows.</li>\n<li>Provides hands-on support during tool rollouts to accelerate user proficiency and resolve adoption barriers.</li>\n<li>Identifies and addresses adoption obstacles through targeted follow-up and adjusted delivery approaches.</li>\n<li>Establishes communities of practice to enable peer learning and sustained engagement with AI tools.</li>\n<li>Monitors usage data and initiates proactive outreach where additional training or support is indicated</li>\n\n</ul></div>"},{"text":"Solution Development (25%)","content":"<div>\n<ul type=\"disc\">\n<li>Designs and builds proof-of-concept AI solutions that demonstrate practical value to specific business functions.</li>\n<li>Develops working prototypes using no-code and low-code AI platforms to illustrate how AI can be applied to real operational challenges.</li>\n<li>Presents and demonstrates prototype solutions to stakeholders, translating outputs into clear business value.</li>\n<li>Builds demonstrations and prototypes using no-code and low-code AI platforms; production development and system integration remain the responsibility of technical IT and development teams.</li>\n<li>Gathers departmental requirements and communicates them to technical teams in plain language.</li>\n<li>Coordinates cross-functional stakeholders to ensure AI tool configurations align with operational workflows.</li>\n<li>Develops standard operating procedures that integrate AI tools into established team workflows.</li>\n\n</ul></div>"},{"text":"Performance Measurement (10%)","content":"<div>\n<ul type=\"disc\">\n<li>Establishes success metrics that capture both adoption rates and measurable business impact.</li>\n<li>Analyzes usage and performance data to assess initiative effectiveness and identify areas for improvement.</li>\n<li>Prepares reports that communicate AI initiative outcomes clearly to leadership audiences.</li>\n<li>Conducts post-implementation reviews to capture lessons learned and apply findings to future rollouts.</li>\n\n</ul></div>"},{"text":"QUALIFICATIONS","content":"<div>\n\n<li data-section-id=\"f0q5ck\" data-start=\"59\" data-end=\"93\">3+ years of related experience</li>\n<li data-section-id=\"rixlfd\" data-start=\"94\" data-end=\"125\">(Honours) Bachelor’s degree</li>\n<li data-section-id=\"1480n0e\" data-start=\"126\" data-end=\"168\">Fluent in English (verbal and written)</li>\n<li data-section-id=\"1qolcbn\" data-start=\"170\" data-end=\"282\">Ability to communicate complex or technical concepts clearly to non-technical audiences (verbal and written)</li>\n<li data-section-id=\"fkl6cf\" data-start=\"283\" data-end=\"430\">Demonstrated ability to build effective working relationships across all organizational levels, including frontline staff and senior leadership</li>\n<li data-section-id=\"1hyz8pg\" data-start=\"431\" data-end=\"515\">Experience designing and delivering training programs for diverse adult learners</li>\n<li data-section-id=\"w4cxhj\" data-start=\"516\" data-end=\"596\">Knowledge of change management principles and technology adoption frameworks</li>\n<li data-section-id=\"yc4s00\" data-start=\"597\" data-end=\"692\">Ability to identify underlying user needs and develop practical, targeted support solutions</li>\n<li data-section-id=\"1vp3w2\" data-start=\"693\" data-end=\"796\">Experience producing user documentation, guides, and job aids that reduce barriers to tool adoption</li>\n<li data-section-id=\"1r1mw0u\" data-start=\"798\" data-end=\"986\">Proficiency with no-code and low-code platforms (e.g., Microsoft Copilot Studio, Power Automate, Claude.ai) to configure and demonstrate AI-powered workflows without custom development</li>\n<li data-section-id=\"hi4srh\" data-start=\"987\" data-end=\"1108\">Ability to develop functional proof-of-concept solutions demonstrating AI applicability to specific business problems</li>\n<li data-section-id=\"aessyu\" data-start=\"1109\" data-end=\"1219\">Familiarity with prompt engineering and understanding of large language model capabilities and limitations</li>\n<li data-section-id=\"l8cq7g\" data-start=\"1220\" data-end=\"1372\">Ability to define and communicate the boundary between enablement-level prototyping and production development requiring IT or developer involvement</li>\n<li data-section-id=\"1h5z84g\" data-start=\"1374\" data-end=\"1481\">Strong cross-functional collaboration skills and ability to align stakeholders around shared objectives</li>\n<li data-section-id=\"1bmvppb\" data-start=\"1482\" data-end=\"1568\">Ability to interpret adoption metrics and usage data to prioritize support efforts</li>\n<li data-section-id=\"t506c4\" data-start=\"1569\" data-end=\"1680\">Working knowledge of AI tools sufficient to guide end-user adoption (deep technical expertise not required)</li>\n<li data-section-id=\"9md780\" data-start=\"1681\" data-end=\"1774\">Familiarity with data privacy principles and responsible AI use in regulated environments</li>\n<li data-section-id=\"14bi1bw\" data-start=\"1776\" data-end=\"1846\" data-is-last-node=\"\">Experience in clinical research or healthcare is considered an asset</li>\n\n</div>"}],"salaryRange":{"min":51000,"max":84500,"currency":"CAD","interval":"per-year-salary"},"text":"Workplace AI Specialist","country":"CA","workplaceType":"remote","opening":"","openingPlain":"","descriptionBody":"<div>The AI Enablement Specialist supports the adoption of artificial intelligence tools across Alimentiv by providing structured training, practical guidance, and implementation support to staff at all levels. This role serves as the primary liaison between technology teams and end users, translating technical capabilities into accessible resources and workflows. Operating at the intersection of technology and people, this role uses accessible AI platforms and no-code tools to prototype and demonstrate solutions &mdash; not to develop or maintain production systems. Reporting to the VP, IT Operations, Security &amp; Workplace AI, the Specialist contributes directly to Alimentiv's AI governance and organizational capability-building objectives.</div>","descriptionBodyPlain":"","hostedUrl":"https://jobs.lever.co/alimentiv-2/e14bcebb-519d-493a-913f-ad61c91faa6f","applyUrl":"https://jobs.lever.co/alimentiv-2/e14bcebb-519d-493a-913f-ad61c91faa6f/apply"}]