Trial Master File Specialist II, Snr TMF – TMF and ALCOA principles experience required

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

📋 Description

• Support the establishment and ongoing maintenance of the Trial Master File (TMF)

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

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

• Assist with the reconciliation of the TMF upon the conclusion of the study

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

• Monitor and conduct quality assessments of documents utilizing internal systems and ALCOA+ principles

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

• Aid in the preparation for study-specific audits

• Participate in in-house project audits as necessary

• Engage in the review and analysis of received audit reports

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

⛳️ Requirements

• Experience in TMF maintenance and quality assessment

• Familiarity with ALCOA Principles

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

• Strong proficiency in Excel

• Capability to assume responsibility for TMF quality

• Ability to independently follow up on various topics

• Excellent English communication skills, both oral and written

🏝️ Benefits

• Availability of remote work

• Emphasis on work-life balance

• Collaborative environment with an international team

• Opportunities for career advancement

• Empowered to take ownership early in the role

• Passionate and cooperative team of specialists

• A diverse and inclusive workplace where every voice is valued