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

• Assist with setup and maintenance of the Trial Master File (TMF)
• Serve as the main point of contact for TMF-related activities on assigned projects
• Process and index project documents in the TMF according to project-specific guidelines and relevant SOPs
• Assist with TMF reconciliation upon study closure
• Ship files to the client when agreed
• Prepare the TMF for archiving
• Track and quality-check documents using internal systems and ALCOA+ principles
• Prepare study team reports or updates on TMF status
• Support preparation for study-specific audits
• Attend in-house project audits when required
• Participate in analysis of received audit reports
• Propose and oversee completion of Corrective and Preventative Action Plans for TMF aspects of projects

• Experience maintaining and quality checking Trial Master Files (TMF)
• Experience with ALCOA principles
• Administrative work experience, preferably in an international Clinical Research setting
• Proficiency in Excel
• Ability to take responsibility for TMF quality
• Ability to follow up on topics independently
• Very good written and oral English communication skills

• Remote work available
• Work-life balance
• Collaborative, international team environment
• Career growth opportunities
• Early ownership and responsibility
• Opportunity to make a meaningful impact by helping bring safe and effective pharmaceutical treatments to patients
• Collaborative team of experts in clinical research, pharmacovigilance, and quality consulting