Manager EDC Administration
Core
Leading EDC system administration activities across a global clinical trial portfolio to ensure efficient, compliant, and scalable administration of the Medidata Rave platform.
Role type
Manager, EDC Administration
Builds
Clinical trial databases and EDC environments for global studies
Domain
Biotechnology / Clinical Data Management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
EDC administration (Medidata Rave), team leadership, resource planning, environment management, regulatory compliance (21 CFR Part 11, ICH-GCP), process improvement, project management
Preferred skills
People management, establishing governance frameworks and SOPs
Technologies
Medidata Rave
Responsibilities
Leading and developing a team of EDC Administration professionals, driving resource planning and workload allocation, managing EDC environments including user access provisioning, ensuring compliance with governance frameworks and regulatory standards, partnering with cross-functional teams for study setup and go-live, monitoring KPIs to improve team performance, contributing to SOPs and continuous improvement initiatives, driving inspection readiness
Seniority
Manager, hands-on leadership
