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

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

📋 Description

• Assist in the establishment and upkeep of the Trial Master File (TMF)

• Act as the primary contact for all TMF-related activities within assigned projects

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

• Support TMF reconciliation at the conclusion of the study

• Dispatch files to the client as agreed and prepare the TMF for archiving purposes

• Monitor and ensure the quality of documents using internal systems alongside ALCOA+ principles

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

• Assist with preparations for study-specific audits

• Participate in-house project audits as needed and contribute to the analysis of 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 checking

• Familiarity with ALCOA Principles

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

• Proficient in Excel

• Capability to take ownership of TMF quality and independently follow up on matters

• Excellent English communication skills, both oral and written

🏝️ Benefits

• Option to work remotely

• Emphasis on work-life balance

• Collaborative environment with an international team

• Opportunities for career advancement

• Trusted ownership and flexibility in roles

• Chance to collaborate with experts in clinical research, pharmacovigilance, and quality consulting