Clinical Document Specialist

Job Summary

A company is looking for a Clinical Document Specialist to support the Clinical Operations department in trial document management.

Key Responsibilities

• Manage the lifecycle of documentation, including filing and classification of trial artifacts in the Veeva eTMF
• Serve as the TMF contact and Subject Matter Expert, providing education on TMF processes
• Execute Quality Control procedures, monitor TMF health, and support audit activities

Required Qualifications

• Bachelor's Degree with 4+ years of clinical experience
• High competency with Veeva VAULT eTMF and knowledge of the TMF Reference Model
• Strong organizational and time management skills
• Ability to work independently and manage competing priorities
• Experience in developing and updating trial-level TMF Plans and Trial Index