Trial Master File Specialist (TMFS) II

📋 Description

• Assist with set up and maintenance of the Trial Master File (TMF).
• Main point of contact for all TMF activities for assigned projects.
• Process and index project documents for the TMF per guidelines and SOPs.
• Assist in reconciliation of TMF at study closure; ship files to client and prepare TMF for
• Track and perform quality checks of documents using ALCOA+ principles.
• Prepare study team reports on TMF status as required.

🎯 Requirements

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

🎁 Benefits

• Join a collaborative, international team with colleagues across North America, South America
• Work on meaningful, complex trials in rare disease and oncology.
• Culture founded on quality, integrity, drive, agility, and belonging.
• Flexible teamwork and commitment to work-life balance.