Clinical Operations

• Assist with setup and maintenance of the Trial Master File (TMF)
• Serve as the main point of contact for TMF-related activities on assigned projects
• Process and index project documents according to project-specific guidelines and relevant SOPs
• Assist with TMF reconciliation upon study closure
• Ship files to the client when agreed
• Prepare the TMF for archiving
• Track documents and perform quality checks using internal systems and ALCOA+ principles
• Prepare study team reports or updates on TMF status
• Support preparations for study-specific audits
• Attend in-house project audits when required
• Participate in analysis of received audit reports
• For TMF Specialist II, propose and oversee completion of Corrective and Preventative Action Plans for TMF aspects of the project

Explore Trial Master File Specialist II – TMF, ALCOA Principles… at ERGOMED. Review requirements and application details.

Clinical Operations jobs in Croatia

Trial Master File Specialist II – TMF, ALCOA Principles Experience Required