eTMF Specialist

Job Summary

A company is looking for an eTMF Specialist.

Key Responsibilities

• Assess eTMF metrics for completeness, timeliness, and quality
• Facilitate TMF QC Reviews and track resolution of identified issues
• Build and maintain partnerships with stakeholders and engage with CROs/Vendors for eTMF responsibilities

Required Qualifications

• 2-5 years of industry experience with TMF/eTMF
• Hands-on experience with TMF QC processes and completeness reviews
• Working knowledge of ICH-GCP, FDA, and EMA regulations
• Familiarity with the CDISC TMF Reference Model
• Experience with Veeva Vault eTMF is a plus