Contract TMF Specialist

Job Summary

A company is looking for a Clinical Trial Master File Specialist to manage and maintain Trial Master Files across clinical studies.

Key Responsibilities:

• Support internal TMF operations to ensure accurate trial documentation and audit readiness
• Collaborate with clinical study teams and CRO partners to manage TMF plans and document flow
• Perform quality control reviews of TMF documents and monitor TMF metrics for process improvement

Qualifications:

• Bachelor's degree in life sciences or a related discipline required
• Minimum 4 years of experience in TMF management within the biotech/pharma industry
• Strong working knowledge of eTMF systems, with experience in Veeva Vault required
• Familiarity with ICH GCP and global regulatory requirements related to TMF documentation
• Prior experience supporting inspection readiness activities is highly desirable