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Sr. TMF Lead

4 weeks, 1 day ago
Brazil, Germany, Hungary, Poland, Romania
Full-time
Lead
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.
  • Monitor TMF health and inspection readiness using TMF metrics, KPIs, and risk-based assessments.
  • 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 defined cadence.
  • Lead study-level audit and inspection readiness activities and support audit responses.
  • Provide strategic TMF oversight across assigned studies, programs, or product lines to ensure consistent TMF execution.
  • Align sponsor-specific TMF requirements with CRO processes and filing models.
  • Identify cross-study trends and risks, and drive mitigation strategies, corrective actions, and targeted training initiatives.
  • Mentor TMF staff and contribute to TMF process updates, SOP revisions, and system enhancements.

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.
  • Experience with 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 leading eTMF platforms such as Veeva Vault or Wingspan.
  • Experience with program-level or portfolio TMF oversight in a sponsor or CRO environment.
  • Strong organizational, analytical, and problem-solving skills.
  • Excellent stakeholder management, communication, and client-facing skills.
  • Clinical research, quality, or regulatory compliance certifications such as SOCRA, ACRP, RAPS, or TMF certification are an asset.

Benefits

  • €59,500 - €99,500 annual salary for candidates located in Germany.
  • Bonus eligibility.
  • Remote full-time, permanent position.
  • Opportunities to work across multiple locations in Germany, Brazil, Poland, Hungary, and Romania.
  • Work for a global, purpose-driven CRO focused on gastrointestinal disease research.

Interested in this position?

Apply directly on the company website

Apply Now

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