Clinical eTMF Specialist

Role: Clinical eTMF Specialist responsible for managing and ensuring quality control of the electronic Trial Master File throughout clinical trial lifecycles. Responsibilities: maintain compliance with GCP, ICH guidelines, SOPs, and regulations; perform quality checks, monitor metrics, and address gaps; collaborate with Clinical Operations, QA, Regulatory Affairs, CROs, and study sites; support inspection readiness, audits, and system upgrades; develop SOPs and training materials. Requirements: Bachelor's in Life Sciences, Clinical Research, or related field; 2-4 years in clinical trial documentation, TMF/eTMF management; solid knowledge of ICH-GCP, FDA, EMA; hands-on with eTMF systems (e.g., Florence, Veeva Vault); experience with TMF CDISC reference model preferred; strong organizational, communication, and teamwork skills; ability to travel. HighValue: clinical trials, eTMF systems, GCP compliance, regulatory readiness, cross-functional collaboration. WorkSetup: not specified; willingness to travel required.