Alimentiv

Clinical Services - TMF Operations

Sr.TMFLead

€60–100k Berlin, Germany FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Senior candidates.

The Brief

“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.

Clinical Services TMF Operations
Problems you'll solve

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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