eTMF Specialist- CDI - H/F
Core
Manage the electronic Trial Master File (eTMF) system to ensure regulatory compliance, quality control, and inspection readiness for global clinical trials.
Role type
eTMF Specialist (Clinical Development)
Builds
Regulatory-compliant clinical trial documentation archives
Domain
Pharmaceutical R&D / Clinical Trials
Required skills
eTMF system management, TMF Veeva Vault, ICH/GCP guidelines, DIA TMF Reference Model, TMF metrics and KPIs, SOP development, archive management, CRO collaboration
Preferred skills
Vendor oversight, system migration management, stakeholder expectation management
Technologies
TMF Veeva Vault
Responsibilities
Manage setup, maintenance, and closeout of eTMFs; perform quality control checks and monitor KPIs; serve as Subject Matter Expert for training and SOP development; oversee IT system compliance and updates; handle archive management
Seniority
Mid-Senior, hands-on IC