The Manager, Trial Master File is responsible for ensuring TMF processes, systems, and documentation comply with global regulatory requirements and support inspection readiness at all times
Job Summary
The Manager, Trial Master File is responsible for ensuring TMF processes, systems, and documentation comply with global regulatory requirements and support inspection readiness at all times.
ICON offers a diverse culture that rewards high performance and provides competitive benefits focused on well-being and work-life balance for employees and their families.
The role partners cross-functionally with Clinical Operations, Clinical Trial Managers, Quality Assurance, and external vendors to maintain a complete, accurate, and inspection-ready TMF.
Matching Summary
The Manager, Trial Master File is responsible for ensuring TMF processes, systems, and documentation comply with global regulatory requirements and support inspection readiness at all times.
Skills & Requirements
Must-have
TMF quality control and reconciliation
eTMF system management
ICH-GCP regulatory compliance
Clinical trial documentation authoring
Cross-functional team collaboration
Inspection readiness support
Nice-to-have
Mentoring TMF managers and specialists
Continuous improvement initiatives
Strong interpersonal and communication skills
Training internal teams and study partners
Problem-solving and analytical skills
Key Requirements
Bachelor’s degree in Life Sciences or related field
5+ years clinical research experience with TMF oversight
Hands-on TMF quality control and inspection support experience
In-depth knowledge of ICH-GCP and TMF Reference Model
Experience with Veeva Vault TMF or similar eTMF systems