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

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

📋 Description

• Assist with the setup and ongoing management of the Trial Master File (TMF).

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

• Process and categorize project documents in accordance with project-specific guidelines and applicable SOPs.

• Aid in the TMF reconciliation process upon conclusion of the study.

• Dispatch files to the client as per agreement.

• Prepare the TMF for archiving.

• Monitor documents and conduct quality checks utilizing internal systems and ALCOA+ principles.

• Generate reports or updates on TMF status for the study team.

• Assist in preparations for study-specific audits.

• Participate in internal project audits as needed.

• Engage in the review of received audit reports.

• For TMF Specialist II, suggest and oversee the execution of Corrective and Preventative Action Plans related to TMF elements of the project.

⛳️ Requirements

• Proven experience in maintaining and performing quality checks on Trial Master Files (TMF).

• Familiarity with ALCOA principles.

• Administrative experience, ideally within an international Clinical Research environment.

• Proficiency in Excel.

• Capability to take ownership of TMF quality.

• Ability to independently follow up on topics.

• Excellent oral and written communication skills in English.

🏝️ Benefits

• Option for remote work.

• Emphasis on work-life balance.

• Opportunities for career advancement.

• Collaborative environment with an international team.

• Trusted ownership and flexibility in responsibilities.

• Engaged and cooperative team of experts.

• Supportive workplace culture.