ALIMENTIV

Healthcare

Sr.TMFLead

£43–74k London, United Kingdom FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Lead candidates.

The Brief

“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.

Healthcare
Problems you'll solve

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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