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

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

📋 Description

• Provide assistance in the establishment and upkeep of the Trial Master File (TMF).

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

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

• Aid in the reconciliation of the TMF upon the conclusion of studies.

• Dispatch files to the client as per agreement.

• Prepare the TMF for archiving purposes.

• Monitor and ensure the quality of documents using internal systems and ALCOA+ standards.

• Create reports or updates for the study team regarding TMF status.

• Assist in the preparation for audits specific to studies.

• Participate in internal project audits as necessary.

• Engage in the evaluation of received audit reports.

• Suggest and manage the execution of Corrective and Preventative Action Plans related to TMF components of projects.

⛳️ Requirements

• Proven experience in maintaining and quality-checking Trial Master Files (TMF).

• Familiarity with ALCOA principles.

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

• Proficient in Excel.

• Ability to take ownership of TMF quality.

• Capability to independently follow up on various topics.

• Excellent written and verbal communication skills in English.

🏝️ Benefits

• Availability of remote work options.

• Emphasis on work-life balance.

• Engaging, collaborative environment with an international team.

• Opportunities for career advancement.

• Early opportunities for ownership and responsibility.

• Chance to make a significant impact by assisting in the development of safe and effective pharmaceutical treatments for patients.

• A team of experts specializing in clinical research, pharmacovigilance, and quality consulting.