Trial Master File Specialist (Contract)

Trial Master File Specialist (Contract)
Location: Remote
Length: 6-month contract
Pay Rate: $45/hr

A clinical-stage biotech company is seeking a skilled TMF Specialist to support trial documentation across multiple studies. This role involves managing eTMF systems, ensuring compliance with GCP standards, and collaborating with internal teams and external partners.

Key Responsibilities

• Oversee TMF operations and document quality from startup to closeout
• Maintain TMF plans, indexes, and configuration standards
• Partner with CROs and vendors to ensure timely, complete documentation
• Support inspection readiness and regulatory compliance
• Serve as eTMF administrator (Veeva Vault)

Qualifications

• Bachelor’s in Life Sciences or related field
• 4+ years of eTMF experience (Veeva Vault required)
• Strong knowledge of TMF reference model and GCP guidelines
• Proven organizational and problem-solving skills
• Inspection readiness experience preferred