Trial Master File Specialist (TMFS) II/Snr TMF - TMF and ALCOA principles experience required

📋 Description

• Assists with set up and maintenance of the Trial Master File (TMF).
• Serves as main point of contact for all TMF-related activities for assigned projects.
• Processing and indexing of project documents for the TMF in accordance with project-specific
• Upon study closure, assists in reconciliation of TMF; ships files to client, if agreed, and
• Tracks and performs quality check of documents using internal systems and ALCOA+ principles.
• Prepares study team reports or updates regarding status of TMF as required.

🎯 Requirements

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

🎁 Benefits

• Collaborative, international team where people share ideas and grow their careers
• Trusted to take ownership early
• Teamwork, flexibility and a real commitment to work-life balance
• Opportunity to make a difference by helping to bring safe and effective pharmaceutical treatment to