eTMF Lead

Join our Global Clinical Research team as an eTMF Lead.

eTMF lead is responsible for eTMF management, including adaptation of Veeva Vault system to the needs of the company and clients, risks management, processes development.

Position is remote / home-based in any European country.

Responsibilities :

• Develop eTMF structure and processes in close cooperation with internal team
• Support in filing documentation in eTMF and quality checks
• Track eTMF metrics compliance in frames of audit readiness concept
• Coordinate oversight of eTMF for assigned projects from the beginning till the end
• Create and maintain comprehensive project documentation
• Develop and update SOPs, WINs in accordance with GCP and local legislation
• Identify quality issues within the project to implement appropriate corrective and preventive action plans
• Lead problem solving and resolution efforts
• Plan and conduct system trainings for internal and external stakeholders
• Support business development by providing input and / or develop proposals for new projects
• Act as Point of Contact for both Internal and External stakeholders

Requirements

Benefits