Senior TMF Specialist

The Senior TMF Specialist supports the ongoing maintenance, quality, and inspection readiness of the Trial Master File (TMF) across assigned clinical studies. This role requires a deep understanding of regulatory requirements and industry best practices related to TMF management.

Requirements

• Bachelor's degree in life sciences or a related field
• 6+ years of experience in clinical operations, TMF management, document management, or a regulated GxP environment
• Strong knowledge of regulatory requirements and guidelines governing TMF maintenance and management, ICH-GCP, TMF Reference Model, and clinical trial documentation requirements

Benefits

• 401k Matching
• Retirement Plan
• Generous Paid Time Off
• Health Insurance
• Dental Insurance
• Vision Insurance