eTMF Spec I

Job description

What You'll Do: - Oversee and guide eTMF processes and specific timelines assessments for each trial; monitor against trial progress and ensure trial activity is in compliance with relevant processes; suggest and implement alternative solutions for issues identified and take corrective action where necessary - Oversee receipt and processing of essential trial documentation including review of content, quality, and completeness - Ensure eTMF compliance and continual inspection readiness - Interact with Regulatory Affairs Study Start-up (RASSU), Clinical Project Assistants / Clinical Project Coordinators (CPAs / CPCs), Clinical Research Associates (CRAs), Clinical Project Managers (CPMs), eTMF Management, and other CTI functions for document corrections, clarification, or resolution of any incomplete and/or incorrect documentation found during content quality review - Participation in internal, Sponsor, and regulatory authority audits and assist in responding to observations - Organize review / regular assessment of eTMF regarding correct naming, filing, as well as completion of essential documents - Ensure eTMF compliance with the achievement of established TMF timelines, milestones...