TMF Team Lead

About the role

The TMF Team Lead will oversee Trial Master File (TMF) operations for multiple clinical studies in Germany, ensuring inspection readiness and regulatory compliance. This position combines operational leadership, quality oversight, and collaboration with international project teams.

Key responsibilities

• Lead and support delivery of TMF services across several clinical studies.
• Maintain TMF inspection readiness and compliance with regulations, internal procedures, and ALCOA principles.
• Perform Records Management Compliance oversight and monitor documentation quality.
• Track KPIs, communicate insights to project teams and external stakeholders.
• Identify operational risks, develop mitigation strategies, and drive continuous improvement.
• Analyze TMF data to support data‑based decision making.
• Develop and maintain project‑specific Quality Management Documents.
• Provide TMF expertise to project team members and mentor junior staff.
• Collaborate with sponsors, external partners, and quality assurance stakeholders.

Required profile

• University degree preferred, ideally in Life Sciences or related field.
• 3‑5 years of experience in clinical research operations and TMF management.
• Strong knowledge of ICH GCP guidelines and regulatory inspection requirements (FDA, EMA, etc.).
• Analytical, organized, and comfortable leading teams in a global environment.

Required skills

• Document Management Systems
• Electronic Trial Master File (eTMF) solutions