TMF Team Lead – Clinical Trial Master File Operations

About the role

We are seeking a TMF Team Lead to oversee Trial Master File (TMF) operations for multiple clinical studies in Switzerland. The role combines operational leadership, quality oversight, and collaboration with international project teams to ensure inspection readiness and regulatory compliance.

Key responsibilities

• Lead delivery of TMF services across several clinical studies, maintaining inspection‑ready files.
• Ensure 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 teams and mentor team members.

Required profile

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

Required skills

• Document management systems
• Electronic Trial Master File (eTMF) platforms