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Sr. TMF Lead

3 weeks, 4 days ago
Brazil, Germany, Hungary, Poland, Romania
Full-time
Senior
Program Manager
Project and Program Management
Apply Now
Alimentiv

Alimentiv

Alimentiv specializes in providing comprehensive clinical research services for gastrointestinal and liver diseases, leveraging a global site network, advanced medical imaging, and biomarker discovery to enhance patient recruitment and accelerate clini...

Professional Services
251-1K
Founded 1986
View All Jobs 41

Description

  • Serve as TMF Lead for complex, high-risk, or strategically important studies and programs.
  • Provide end-to-end TMF oversight from study start-up through close-out, transfer, and archival.
  • Use TMF metrics, KPIs, and risk-based assessments to monitor TMF health and inspection readiness.
  • Partner with Project Management and Functional Leads to manage TMF deliverables, risks, and escalations.
  • Deliver TMF oversight reports and status updates to sponsors and internal stakeholders on a regular cadence.
  • Lead study-level audit and inspection readiness activities and support audit responses.
  • Align sponsor-specific TMF requirements with CRO processes, filing models, and study team expectations.
  • Identify cross-study trends, systemic risks, and process gaps, then drive mitigation actions, corrective actions, and training.
  • Act as a TMF subject matter expert for management plans, filing guidance, governance discussions, and compliance issues.
  • Mentor TMF Leads, TMFAs, and TMFCs while developing and delivering TMF training materials and supporting process improvements.

Requirements

  • 7-9 years of recent, related TMF experience within a Contract Research Organization.
  • Honour's Bachelor's degree, or an equivalent combination of education and experience.
  • Strong working knowledge of ICH-GCP, 21 CFR Part 11, EU CTR, and other global regulatory requirements.
  • Knowledge of the TMF Reference Model and risk-based TMF management principles.
  • Experience with inspection readiness activities and TMF audits, including FDA, EMA, and MHRA inspections.
  • Experience with procedural gap analysis and TMF issue resolution.
  • Experience leading eTMF platforms such as Veeva Vault or Wingspan.
  • Experience with TMF governance, quality oversight, and program-level or portfolio TMF oversight.
  • Ability to advise sponsors and cross-functional stakeholders on TMF strategy and risk management.
  • Certifications related to clinical research, quality, or regulatory compliance, such as SOCRA, ACRP, RAPS, or TMF certification, are an asset.

Benefits

  • £43,000 - £73,500 annual salary.
  • Bonus eligibility.
  • Full-time, permanent role.
  • Remote working arrangement.
  • Opportunity to work across multiple UK locations, including London, Belfast, Cambridge, Edinburgh, Manchester, Glasgow, and Oxford.

Interested in this position?

Apply directly on the company website

Apply Now

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