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

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

📋 Description

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

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

• Process and organize project documents within the TMF in accordance with project-specific protocols and relevant SOPs

• Aid in TMF reconciliation at the conclusion of the study

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

• Monitor and verify documents utilizing internal systems and ALCOA+ principles

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

• Assist in the preparation for study-specific audits

• Participate in internal project audits when necessary and engage in the analysis of audit reports

• For TMF Specialist II, suggest and oversee the completion of Corrective and Preventative Action Plans related to project TMF components

⛳️ Requirements

• Experience in TMF maintenance and quality assurance

• Familiarity with ALCOA Principles

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

• Proficiency in Excel

• Ability to take ownership of TMF quality and independently follow up on issues

• Excellent oral and written communication skills in English

🏝️ Benefits

• Availability for remote work

• Emphasis on work-life balance

• A collaborative, international team atmosphere

• Opportunities for career advancement

• Chance to take ownership early in projects

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