Trial Master File Specialist (TMFS) II

📋 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

• Quality-focused culture with integrity and trust.
• Drive and passion for delivering outcomes that matter to patients.
• Agility and responsiveness in a collaborative international team.
• Belonging and collaborative partnerships across global offices.