Senior Specialist, Trial Master File

Job Summary

A company is looking for a Senior Specialist, Global Trial Master File.

Key Responsibilities

• Manage all Trial Master File (TMF) operations, ensuring quality and compliance
• Develop and maintain the TMF Plan and TMF Index, collaborating with project leads
• Generate monthly TMF metric reports and oversee TMF maintenance in the eTMF system

Required Qualifications

• 4 years of experience in a clinical research environment or equivalent combination of education and experience
• Trained in clinical research regulatory requirements, including ICH and GCP
• Knowledge of Standard Operating Procedures (SOPs) and regulatory guidelines
• Experience with TMF management processes and documentation
• Familiarity with eTMF systems and compliance checks