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

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

📋 Description

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

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

• Process and catalog project documents in the TMF following project-specific guidelines and standard operating procedures (SOPs)

• Aid in TMF reconciliation at the conclusion of the study

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

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

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

• Assist in preparations for study-specific audits

• Participate in internal project audits when necessary

• Engage in the evaluation of received audit reports

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

⛳️ Requirements

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

• Familiarity with ALCOA principles

• Administrative experience, preferably within an international Clinical Research environment

• Proficient in Excel

• Capability to take responsibility for the quality of TMF

• Ability to independently follow up on various topics

• Excellent oral and written communication skills in English

🏝️ Benefits

• Flexible/remote work options (employees may work from home)

• Emphasis on work-life balance

• Opportunities for career advancement

• Collaborative environment with an international team

• Empowerment and the chance to make a significant impact

• Supportive workplace culture

• Exposure to experts in clinical research, pharmacovigilance, and quality consulting