Trial Master File Specialist (TMFS) II / Senior TMF

About the role

Ergomed, a specialist clinical research organisation focused on rare disease and select oncology indications, is looking for a Trial Master File Specialist II (Senior TMF) in Zagreb. The role supports the setup and maintenance of the Trial Master File (TMF) and acts as the main point of contact for TMF-related activities on assigned projects.

Key responsibilities

• Assist with the setup and maintenance of the Trial Master File (TMF).
• Serve as the main point of contact for all TMF-related activities for assigned projects.
• Process and index project documents for the TMF according to project-specific guidelines and relevant SOPs.
• After study closure, help reconcile the TMF, ship files to the client if agreed, and prepare the TMF for archiving.
• Track and perform quality checks of documents using internal systems and ALCOA+ principles.
• Prepare study team reports or updates on TMF status as required.
• Support preparations for study-specific audits, attend in-house project audits if needed, and take part in analysing received audit reports.
• The TMF Specialist II can propose and oversee the completion of a Corrective and Preventive Action Plan covering all TMF aspects of the project.

Required profile

• Experience maintaining and quality-checking TMFs.
• Knowledge of ALCOA principles.
• Administrative experience, preferably in an international clinical research setting.
• Ability to take responsibility for TMF quality and follow up on topics independently.
• Very good spoken and written English.

Required skills

• Proficiency in Excel.
• Understanding of ALCOA+ principles.