Trial Master File Manager

Job Summary

A company is looking for a Trial Master File (TMF) Manager responsible for managing essential regulatory documents in compliance with industry guidelines.

Key Responsibilities

• Lead the configuration, validation, and management of the eTMF system to ensure compliance and usability
• Develop and implement TMF processes, including SOPs, templates, and training
• Conduct quality control reviews and monitor TMF health status across clinical studies

Required Qualifications

• Bachelor's degree (BS/BA) or equivalent training and experience
• 3-5 years of experience in biotech, pharma, CRO, or TMF/document management settings
• Strong knowledge of TMF operations and regulatory guidelines (ICH-GCP, FDA, EMA, PMDA)
• Solid understanding of clinical trial operations and study/site management
• Proven ability to work independently and collaboratively in a fast-paced environment