Clinical Trial Associate / TMF Manager

Location: Basel
Contract: 12 Months
Start Date: ASAP
Workload: 100%

This position is a great match for someone who enjoys the operational side of clinical trials and has solid experience managing the Trial Master File (TMF). You’ll support the Development Operations Leader and the Clinical Trial Team in the day-to-day delivery of global studies while taking ownership of TMF quality, compliance, and oversight.

Your Tasks: 

• Oversee the setup, maintenance, and quality of the TMF across global trials
• Ensure documents are inspection-ready, accurate, and compliant with ICH-GCP and SOPs
• Support trial operations: tracking timelines, metrics, site activity, and document flow
• Prepare agendas and minutes for Clinical Trial Team (CTT) meetings
• Manage trial documentation and assist in vendor selection and oversight (e.g., eTMF vendor)
• Monitor and report on vendor invoices and trial budget progress
• Coordinate virtual and in-person team meetings and investigator meetings
• Contribute to process improvements and operational excellence initiatives
• Provide regular updates and operational input to the Development Operations Leader

Your Profile:

• 5+ years’ experience in clinical operations, ideally with global studies
• Strong TMF expertise and knowledge of clinical documentation standards
• Comfortable using eTMF and EDMS platforms
• Solid understanding of ICH-GCP and regulatory requirements
• Vendor oversight experience is a plus

Please apply directly online with your CV.

**Please only apply if you are eligible to work in Switzerland and the EU*
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