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 for 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 and 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 preparations for study-specific audits
• Attend in-house project audits when required and participate in analysis of audit reports
• Propose and oversee completion of Corrective and Preventative Action Plans for TMF aspects of projects

• TMF maintenance and quality check experience
• Experience with ALCOA Principles
• Administrative work experience, preferably in an international Clinical Research setting
• Proficiency in Excel
• Ability to take responsibility for TMF quality and follow up on topics independently
• Very good English oral and written communication skills

• Remote work availability
• Work-life balance
• Collaborative international team environment
• Career growth opportunities
• Trusted ownership and responsibility
• Opportunity to make an impact through purposeful work
• Passionate and collaborative team of clinical research, pharmacovigilance, and quality consulting experts