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Alimentiv 28h ago
New
EUR 59500–99500/yr

Sr. TMF Lead

GermanyGermany·BerlinRemoteFull-time, Permanentsenior
OtherLead
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Quick Summary

Requirements Summary

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. Clo

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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. 
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 inspection readiness.
  • Partner with Project Management and Functional Leads to proactively manage TMF deliverables and risks.
  • Ensure TMF oversight reports and status updates are delivered to sponsors and internal stakeholders on a defined
    cadence.
  • Lead study-level audit and inspection readiness activities and support audit responses.
    • Program / Product Line TMF Oversight & Delivery (25–30%)
  • Provide strategic, study-facing oversight across assigned studies, programs, or product lines to ensure consistent
    TMF execution.
  • Align sponsor-specific TMF requirements with CRO processes and filing models, ensuring clear expectations for
    study teams.
  • Utilize TMF metrics, KPIs, and risk-based assessments to ensure TMFs meet standards for quality, completeness,
    timeliness, and inspection readiness.
  • Identify cross-study or systemic trends and risks; develop and drive mitigation strategies, corrective actions, and
    targeted training initiatives.
  • Act as TMF SME for TMF Management Plans, file and guidance.
  • Support sponsor-facing TMF strategy discussions and governance forums.
  • Act as escalation point for complex TMF risks and compliance issues.
    • Study-Facing Process Alignment & Continuous Improvement (10–15%)
  • Ensure consistent application of TMF processes, standards, and quality expectations across assigned studies.
  • Identify study-facing process gaps, inefficiencies, or compliance risks and escalate recommendations to TMF
    Operations (TMFO) and Quality.
  • Contribute subject matter expertise to TMF process updates, SOP revisions, and system enhancements led by
    TMFO.
  • Support implementation of updated TMF processes, tools, and system changes within study teams.
    • Training, 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. 
  • Develop and deliver advanced TMF training materials for study teams and functional stakeholders.
  • Partner with Quality Training & Compliance (QTC) to ensure training reflects current processes and inspection
    expectations.
  • Serve as a knowledge resource for complex TMF scenarios, regulatory expectations, and inspection readiness.
    • 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
  • Equivalent combination of education and experience may be considered. 
  • Strong 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 (e.g., Veeva Vault, Wingspan)
  • TMF governance, quality oversight, and inspection readiness
  • Strong 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
  • Certifications related to clinical research, quality, or regulatory compliance (e.g., SOCRA, ACRP, RAPS, TMF
    certification) would be an asset
  • Continuous improvement mindset and ability to provide study-level process guidance

    • Location & Eligibility

    Where is the job
    Berlin, Germany
    Remote within one country
    Who can apply
    DE

    Listing Details

    Posted
    May 30, 2026
    First seen
    May 30, 2026
    Last seen
    May 30, 2026

    Posting Health

    Days active
    0
    Repost count
    0
    Trust Level
    87%
    Scored at
    May 30, 2026

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    Sr. TMF LeadEUR 59500–99500
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