ALIMENTIV
Healthcare
Sr.TMFLead
Neural analysis suggests this role is
optimal for Lead candidates.
“Sr. TMF Lead at ALIMENTIV. Skills: TMF oversight, Inspection readiness, Risk management, Stakeholder management. Provide TMF oversight. Ensure TMF quality”
What You'll Achieve.
Ensure TMF quality; Ensure TMF compliance; Ensure inspection readiness
Industry & Context.
Problem-solving; Issue resolution; Root cause analysis
What They're Looking For.
Must Have
7-9 years TMF experience, Honour's Bachelor's degree, ICH-GCP knowledge, 21 CFR Part 11 knowledge, EU CTR knowledge, Global regulatory requirements knowledge, TMF Reference Model knowledge, Risk-based TMF management knowledge, Inspection readiness experience, TMF audits experience, Procedural gap analysis experience, Issue resolution experience, eTMF platforms experience, Organizational skills, Analytical skills, Problem-solving skills, Stakeholder management skills, Client-facing skills, Global matrixed environment experience, Program-level TMF oversight experience, Portfolio TMF oversight experience, Study alignment experience, Risk management experience, Advise sponsors experience, Advise cross-functional stakeholders experience, TMF strategy experience, TMF risk management experience
Nice to Have
Certifications in clinical research, Certifications in quality, Certifications in regulatory compliance, TMF certification
What You'll Do.
Provide TMF oversight
Ensure TMF compliance
Ensure inspection readiness
Align TMF requirements
Apply risk-based TMF management
Advise internal stakeholders
Provide end-to-end TMF oversight
Partner with Project Management
Partner with Functional Leads
Manage TMF deliverables
Deliver TMF oversight reports
Deliver status updates
Lead audit readiness activities
Lead inspection readiness activities
Support audit responses
Provide strategic oversight
Ensure consistent TMF execution
Ensure TMFs meet standards
Identify systemic trends
Develop mitigation strategies
Drive corrective actions
Drive targeted training
Support TMF strategy discussions
Support governance forums
Act as escalation point
Ensure consistent application of TMF processes
Ensure consistent application of TMF standards
Ensure consistent application of quality expectations
Identify process gaps
Identify inefficiencies
Identify compliance risks
Escalate recommendations
Contribute expertise to process updates
Contribute expertise to SOP revisions
Contribute expertise to system enhancements
Support implementation of updated TMF processes
Support implementation of updated TMF tools
Support implementation of system changes
Provide mentoring guidance
Provide oversight guidance
Develop training materials
Deliver training materials
Partner with Quality Training & Compliance
Ensure training reflects current processes
Ensure training reflects inspection expectations
Serve as knowledge resource
How You'll Work.
Team & Collaboration
Internal stakeholders; Project Management; Functional Leads; Study teams; Cross-functional stakeholders; Quality Training & Compliance
Communication Scope
Client-facing; Sponsor discussions; Status updates
Process & Methodology
Program 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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