{"schemaVersion":"jobsearcher.job.v1","id":"549e9c9ee8d4964a39b27c21","url":"https://jobsearcher.com/jobs/549e9c9ee8d4964a39b27c21","canonicalUrl":"https://jobsearcher.com/jobs/549e9c9ee8d4964a39b27c21","title":"Sr. TMF Lead","description":"ABOUT ALIMENTIV 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.\r\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.\r\nIf you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you.\r\nTHE OPPORTUNITY The Sr. TMF Lead provides expert, study-facing TMF oversight for assigned studies and complex programs, ensuring TMF quality, compliance, and continuous inspection readiness. Acting as a TMF subject matter expert (SME), the role aligns sponsor-specific TMF requirements with CRO processes, applies risk-based TMF management practices, and leads TMF execution from study start-up through close-out. The Sr. TMF Lead independently advises sponsors and internal stakeholders, mentors TMF staff, and contributes subject matter expertise to TMF process and system improvements.\r\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.\r\nClosing date June 12th, 2026, or until successful candidate identified.\r\nThe role Individual TMF Delivery (40–45%) Serve as TMF Lead for complex, high-risk, or strategically important studies or programs.\r\nProvide end-to-end TMF oversight from study start-up through close-out, transfer, and archival.\r\nUtilize TMF metrics, KPIs, and risk-based assessments to monitor TMF health and inspection readiness.\r\nPartner with Project Management and Functional Leads to proactively manage TMF deliverables and risks.\r\nEnsure TMF oversight reports and status updates are delivered to sponsors and internal stakeholders on a defined cadence.\r\nLead study-level audit and inspection readiness activities and support audit responses.\r\nProgram / Product Line TMF Oversight & Delivery (25–30%) Provide strategic, study-facing oversight across assigned studies, programs, or product lines to ensure consistent TMF execution.\r\nAlign sponsor-specific TMF requirements with CRO processes and filing models, ensuring clear expectations for study teams.\r\nUtilize TMF metrics, KPIs, and risk-based assessments to ensure TMFs meet standards for quality, completeness, timeliness, and inspection readiness.\r\nIdentify cross-study or systemic trends and risks; develop and drive mitigation strategies, corrective actions, and targeted training initiatives.\r\nAct as TMF SME for TMF Management Plans, file and guidance.\r\nSupport sponsor-facing TMF strategy discussions and governance forums.\r\nAct as escalation point for complex TMF risks and compliance issues.\r\nStudy-Facing Process Alignment & Continuous Improvement (10–15%) Ensure consistent application of TMF processes, standards, and quality expectations across assigned studies.\r\nIdentify study-facing process gaps, inefficiencies, or compliance risks and elevate recommendations to TMF Operations (TMFO) and Quality.\r\nContribute subject matter expertise to TMF process updates, SOP revisions, and system enhancements led by TMFO.\r\nSupport implementation of updated TMF processes, tools, and system changes within study teams.\r\nTraining, Mentoring and Onboarding (10–15%) Provide advanced mentoring and TMF oversight guidance to TMF Leads, TMFAs, and TMFCs to ensure consistent application of TMF standards.\r\nDevelop and deliver advanced TMF training materials for study teams and functional stakeholders.\r\nPartner with Quality Training & Compliance (QTC) to ensure training reflects current processes and inspection expectations.\r\nServe as a knowledge resource for complex TMF scenarios, regulatory expectations, and inspection readiness.\r\nAbout You Education & Experience Minimum 7-9 years of recent, related experience in TMF function within a Contract Research Organization, along with an Honour's Bachelor's degree\r\nEquivalent combination of education and experience may be considered.\r\nStrong working knowledge of ICH-GCP, 21 CFR Part 11, EU CTR, and other global regulatory requirements\r\nTMF Reference Model and risk-based TMF management principles\r\nExperience with inspection readiness activities (FDA, EMA, MHRA, etc) and TMF audits\r\nProcedural gap analysis and issue resolution in TMF contexts\r\nExperience with leading eTMF platforms (e.g., Veeva Vault, Wingspan)\r\nTMF governance, quality oversight, and inspection readiness\r\nStrong organizational, analytical, and problem-solving skills\r\nExcellent stakeholder management, communication, and client-facing skills\r\nAbility to work effectively in a global, matrixed environment\r\nProgram-level or portfolio TMF oversight experience, including study alignment and risk management within a sponsor or CRO environment\r\nDemonstrated ability to advise sponsors and cross-functional stakeholders on TMF strategy and risk management\r\nCertifications related to clinical research, quality, or regulatory compliance (e.g., SOCRA, ACRP, RAPS, TMF certification) would be an asset\r\nContinuous improvement mindset and ability to provide study-level process guidance\r\n€59,500 - €99,500 a year\r\n* Bonus\r\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.\r\nJ-18808-Ljbffr","company":"Medium","rawCompany":"medium","city":"Berlin","state":"CT","isRemote":false,"isActive":false,"createdAt":"2026-08-07T00:55:36.226Z","occupations":[{"code":"11-9121.00","title":"Natural Sciences Managers","slug":"natural-sciences-managers"},{"code":"11-3131.00","title":"Training and Development Managers","slug":"training-and-development-managers"},{"code":"15-1299.09","title":"Information Technology Project Managers","slug":"information-technology-project-managers"}],"industries":[{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"541611","title":"Administrative Management and General Management Consulting Services","slug":"administrative-management-and-general-management-consulting-services"},{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Sr. TMF Lead","description":"ABOUT ALIMENTIV 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.\r\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.\r\nIf you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you.\r\nTHE OPPORTUNITY The Sr. TMF Lead provides expert, study-facing TMF oversight for assigned studies and complex programs, ensuring TMF quality, compliance, and continuous inspection readiness. Acting as a TMF subject matter expert (SME), the role aligns sponsor-specific TMF requirements with CRO processes, applies risk-based TMF management practices, and leads TMF execution from study start-up through close-out. The Sr. TMF Lead independently advises sponsors and internal stakeholders, mentors TMF staff, and contributes subject matter expertise to TMF process and system improvements.\r\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.\r\nClosing date June 12th, 2026, or until successful candidate identified.\r\nThe role Individual TMF Delivery (40–45%) Serve as TMF Lead for complex, high-risk, or strategically important studies or programs.\r\nProvide end-to-end TMF oversight from study start-up through close-out, transfer, and archival.\r\nUtilize TMF metrics, KPIs, and risk-based assessments to monitor TMF health and inspection readiness.\r\nPartner with Project Management and Functional Leads to proactively manage TMF deliverables and risks.\r\nEnsure TMF oversight reports and status updates are delivered to sponsors and internal stakeholders on a defined cadence.\r\nLead study-level audit and inspection readiness activities and support audit responses.\r\nProgram / Product Line TMF Oversight & Delivery (25–30%) Provide strategic, study-facing oversight across assigned studies, programs, or product lines to ensure consistent TMF execution.\r\nAlign sponsor-specific TMF requirements with CRO processes and filing models, ensuring clear expectations for study teams.\r\nUtilize TMF metrics, KPIs, and risk-based assessments to ensure TMFs meet standards for quality, completeness, timeliness, and inspection readiness.\r\nIdentify cross-study or systemic trends and risks; develop and drive mitigation strategies, corrective actions, and targeted training initiatives.\r\nAct as TMF SME for TMF Management Plans, file and guidance.\r\nSupport sponsor-facing TMF strategy discussions and governance forums.\r\nAct as escalation point for complex TMF risks and compliance issues.\r\nStudy-Facing Process Alignment & Continuous Improvement (10–15%) Ensure consistent application of TMF processes, standards, and quality expectations across assigned studies.\r\nIdentify study-facing process gaps, inefficiencies, or compliance risks and elevate recommendations to TMF Operations (TMFO) and Quality.\r\nContribute subject matter expertise to TMF process updates, SOP revisions, and system enhancements led by TMFO.\r\nSupport implementation of updated TMF processes, tools, and system changes within study teams.\r\nTraining, Mentoring and Onboarding (10–15%) Provide advanced mentoring and TMF oversight guidance to TMF Leads, TMFAs, and TMFCs to ensure consistent application of TMF standards.\r\nDevelop and deliver advanced TMF training materials for study teams and functional stakeholders.\r\nPartner with Quality Training & Compliance (QTC) to ensure training reflects current processes and inspection expectations.\r\nServe as a knowledge resource for complex TMF scenarios, regulatory expectations, and inspection readiness.\r\nAbout You Education & Experience Minimum 7-9 years of recent, related experience in TMF function within a Contract Research Organization, along with an Honour's Bachelor's degree\r\nEquivalent combination of education and experience may be considered.\r\nStrong working knowledge of ICH-GCP, 21 CFR Part 11, EU CTR, and other global regulatory requirements\r\nTMF Reference Model and risk-based TMF management principles\r\nExperience with inspection readiness activities (FDA, EMA, MHRA, etc) and TMF audits\r\nProcedural gap analysis and issue resolution in TMF contexts\r\nExperience with leading eTMF platforms (e.g., Veeva Vault, Wingspan)\r\nTMF governance, quality oversight, and inspection readiness\r\nStrong organizational, analytical, and problem-solving skills\r\nExcellent stakeholder management, communication, and client-facing skills\r\nAbility to work effectively in a global, matrixed environment\r\nProgram-level or portfolio TMF oversight experience, including study alignment and risk management within a sponsor or CRO environment\r\nDemonstrated ability to advise sponsors and cross-functional stakeholders on TMF strategy and risk management\r\nCertifications related to clinical research, quality, or regulatory compliance (e.g., SOCRA, ACRP, RAPS, TMF certification) would be an asset\r\nContinuous improvement mindset and ability to provide study-level process guidance\r\n€59,500 - €99,500 a year\r\n* Bonus\r\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.\r\nJ-18808-Ljbffr","datePosted":"2026-08-07T00:55:36.226Z","dateModified":"2026-08-07T00:55:36.226Z","hiringOrganization":{"@type":"Organization","name":"Medium","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Berlin","addressRegion":"CT","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"549e9c9ee8d4964a39b27c21"},"url":"https://jobsearcher.com/jobs/549e9c9ee8d4964a39b27c21"}}