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

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

📋 Description

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

• Act as the primary liaison for TMF-related tasks for designated projects

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

• Support TMF reconciliation at the conclusion of studies

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

• Monitor and perform quality checks on documents utilizing internal systems and ALCOA+ principles

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

• Assist in preparations for audits specific to the study

• Participate in internal project audits as necessary and contribute to the evaluation of audit reports

• Recommend and ensure the execution of Corrective and Preventative Action Plans concerning TMF elements of projects

⛳️ Requirements

• Experience in TMF maintenance and quality control

• Familiarity with ALCOA Principles

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

• Proficient in Excel

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

• Excellent English communication skills, both spoken and written

🏝️ Benefits

• Availability of remote work

• Emphasis on work-life balance

• Collaborative environment with an international team

• Opportunities for career advancement

• Empowered ownership and accountability

• Chance to create an impact through meaningful work

• Engaged and cooperative team of experts in clinical research, pharmacovigilance, and quality consulting