Clinical Operations

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

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

Clinical Operations jobs in Bulgaria

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