Trial Master File Specialist II/Snr, TMF and ALCOA Principles Experience Required

This is a fully remote position, open to applicants in Serbia.

📋 Description

• Assist with the establishment and ongoing management of the Trial Master File (TMF)

• Act as the primary contact for TMF-related tasks on assigned projects

• Process and categorize project documents in the TMF in accordance with project-specific guidelines and applicable SOPs

• Aid in TMF reconciliation at the conclusion of the study

• Dispatch files to the client as per agreement

• Prepare the TMF for archival storage

• Monitor and perform quality checks on documents using internal systems and ALCOA+ standards

• Generate reports for the study team or updates on TMF status

• Assist in preparations for study-specific audits

• Participate in in-house project audits as necessary

• Contribute to the analysis of received audit reports

• For TMF Specialist II, suggest and oversee the implementation of Corrective and Preventative Action Plans concerning TMF elements of the project

⛳️ Requirements

• Experience in TMF maintenance and quality assurance

• Familiarity with ALCOA Principles

• Background in administrative work, ideally within an international Clinical Research environment

• Strong proficiency in Excel

• Capacity to take ownership of TMF quality

• Ability to independently follow up on various topics

• Excellent oral and written communication skills in English

🏝️ Benefits

• Option for remote work

• Emphasis on work-life balance

• Collaborative environment within an international team

• Opportunities for career advancement

• Trusted ownership and autonomy in work

• A passionate and cooperative team of professionals

• A diverse and inclusive workplace where every voice is valued