Alimentiv
Clinical Services - TMF Operations
Sr.TMFLead
Neural analysis suggests this role is
optimal for Senior candidates.
“Sr. TMF Lead at Alimentiv. Skills: TMF oversight, Compliance, Risk management. Provide expert, study-facing TMF oversight. Ensure TMF quality, compliance, and inspection readiness”
Industry & Context.
organizational, analytical, and problem-solving skills
What They're Looking For.
Must Have
7-9 years of recent, related experience in TMF function within a Contract Research Organization, working knowledge of ICH-GCP, 21 CFR Part 11, EU CTR, and other global regulatory requirements, TMF Reference Model and risk-based TMF management principles, Experience with inspection readiness activities (FDA, EMA, MHRA, etc) and TMF audits, Procedural gap analysis and issue resolution in TMF contexts, Experience with leading eTMF platforms, TMF governance, quality oversight, and inspection readiness, organizational, analytical, and problem-solving skills, Excellent stakeholder management, communication, and client-facing skills, Ability to work effectively in a global, matrixed environment, Program-level or portfolio TMF oversight experience, including study alignment and risk management within a sponsor or CRO environment, Demonstrated ability to advise sponsors and cross-functional stakeholders on TMF strategy and risk management
Nice to Have
Certifications related to clinical research, quality, or regulatory compliance (e.g., SOCRA, ACRP, RAPS, TMF certification), Continuous improvement mindset and ability to provide study-level process guidance
What You'll Do.
study-facing TMF oversight
and inspection readiness
Act as TMF subject matter expert (SME)
Align sponsor-specific TMF requirements with CRO processes
Apply risk-based TMF management practices
Lead TMF execution from study start-up through close-out
Advise sponsors and internal stakeholders
Contribute subject matter expertise to TMF process and system improvements
Serve as TMF Lead for complex studies
Provide end-to-end TMF oversight
and risk-based assessments
Monitor TMF health and inspection readiness
Partner with Project Management and Functional Leads
Proactively manage TMF deliverables and risks
Ensure TMF oversight reports and status updates are delivered
Lead study-level audit and inspection readiness activities
Support audit responses
study-facing oversight across assigned studies
Ensure consistent TMF execution
Align sponsor-specific TMF requirements with CRO processes
Ensure TMFs meet standards for quality
Identify cross-study or systemic trends
Develop and drive mitigation strategies
Act as TMF SME for TMF Management Plans
Support sponsor-facing TMF strategy discussions
Act as escalation point for complex TMF risks
Ensure consistent application of TMF processes
Identify study-facing process gaps
Escalate recommendations to TMF Operations
Contribute subject matter expertise to TMF process updates
Support implementation of updated TMF processes
Provide advanced mentoring and TMF oversight guidance
Develop and deliver advanced TMF training materials
Partner with Quality Training & Compliance
Serve as a knowledge resource for complex TMF scenarios
How You'll Work.
Team & Collaboration
Partner with Project Management and Functional Leads; Advise sponsors and internal stakeholders; Advise sponsors and cross-functional stakeholders
Communication Scope
Excellent stakeholder management, communication, and client-facing skills
Process & Methodology
Program-level or portfolio TMF oversight experience, study alignment, risk management
Full Job Description
## 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. 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. If you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you. THE 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. Positions 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. Closing date: June 12th, 2026, or until successful candidate identified. ## The role Individual TMF Delivery (40–45%) Serve as TMF Lead for complex, high-risk, or strategically important studies or programs. Provide end-to-end TMF oversight from study start-up through close-out, transfer, and archival. Utilize TMF metrics, KPIs, and risk-based assessments to monitor TMF health and inspectio
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