Manager EDC Administration
On-site · Hyderabad, Telangana, India
Job Summary
Lead and develop an EDC Administration team responsible for Medidata Rave administration across Regeneron’s global clinical trial portfolio. Drive resource planning, environment configuration, user provisioning, access controls, and deactivation within Medidata platforms; ensure governance alignment with 21 CFR Part 11 and ICH-GCP; collaborate with Database Developers and Study Data Managers for study setup, UAT, and go-live; monitor KPIs and drive continuous improvement, SOPs, and inspection readiness. Office-based role on-site at Hyderabad, India, with a strong emphasis on governance, regulatory compliance, and cross-functional leadership in a regulated biotech/pharma environment.
Required Qualifications
- Bachelor’s degree in mathematics, science, information systems, or a related field
- Minimum of 7+ years of experience in biotechnology, pharmaceutical, or healthcare industry
- At least 4+ years of direct experience in EDC or clinical systems administration
- Prior people management or team lead experience preferred
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