Trial Master File Specialist II (TMFS) - TMF and ALCOA

About the role

Ergomed is a specialist clinical research organisation focused on rare disease and select oncology indications, working with small to midsize biotech companies on early-phase trials. It is looking for a Trial Master File Specialist II (TMFS) in Novi Sad, based in the Clinical Trial Administration field. The role is full-time and centres on maintaining the Trial Master File (TMF) and ensuring document quality.

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 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 in TMF maintenance and quality checks.
• Knowledge of ALCOA principles.
• Administrative work 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.