Trial Master File Specialist II/Senior TMF, TMF and ALCOA principles experience required

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

📋 Description

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

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

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

• Aid in TMF reconciliation at the conclusion of studies

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

• Monitor and validate documents utilizing internal systems and adhere to ALCOA+ principles

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

• Assist in the preparation for study-specific audits

• Participate in in-house project audits when necessary and contribute to the analysis of audit reports

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

⛳️ Requirements

• Experience in TMF maintenance and quality assurance

• Familiarity with ALCOA Principles

• Background in administrative roles, preferably within an international Clinical Research context

• Proficiency in Excel

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

• Strong oral and written communication skills in English

🏝️ Benefits

• Availability for remote work

• Emphasis on work-life balance

• Collaborative environment with an international team

• Opportunities for career advancement

• Chance to take on responsibilities early in your career

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