Trial Master File Specialist (TMFS) II

📋 Description

• Assists with set up and maintenance of the TMF.
• Serves as main point of contact for TMF activities for assigned projects.
• Processing and indexing of project documents for the TMF per guidelines and SOPs.
• Assists in reconciliation and archiving of TMF at study closure.
• Tracks and performs quality checks of documents using ALCOA+ principles.
• Supports study team reports and audits; may oversee CAPA related to TMF.

🎯 Requirements

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

🎁 Benefits

• Global, collaborative team with colleagues across multiple regions
• Commitment to work-life balance
• Culture built on quality, integrity, agility and belonging