Trial Master File Specialist II – TMF, ALCOA Principles

This is a fully remote position, open to applicants in Bosnia and Herzegovina.

📋 Description

• Assist in the setup and ongoing maintenance of the Trial Master File (TMF)

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

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

• Aid in TMF reconciliation upon the closure of studies

• Dispatch files to clients, if mutually agreed, and prepare the TMF for archiving

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

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

• Assist in preparations for audits specific to the study

• Participate in internal project audits as required

• Engage in the evaluation of received audit reports

• Recommend and supervise the execution of Corrective and Preventative Action Plans related to TMF aspects of the project

⛳️ Requirements

• Experience in TMF maintenance and quality assurance

• Familiarity with ALCOA Principles

• Administrative experience, ideally within an international Clinical Research environment

• Proficiency in Microsoft Excel

• Ability to assume responsibility for TMF quality

• Capability to independently follow up on issues

• Excellent oral and written communication skills in English

🏝️ Benefits

• Option for remote work

• Emphasis on work-life balance

• Opportunities for career advancement

• Collaborative environment within an international team

• Chance to contribute positively to patient care

• Supportive workplace culture

• Team of passionate and collaborative experts

• Inclusive and welcoming environment