Regeneron
SeniorSpecialist,EDCAdministration
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“Senior Specialist, EDC Administration at Regeneron. Skills: Medidata Rave administration, EDC system administration, User access management. Administer Medidata Rave user management. Configure and maintain study environments”
Industry & Context.
Problem-solving
What They're Looking For.
Must Have
4+ years experience in biotech, pharma, or healthcare, 2+ years direct EDC administration or clinical systems administration, Medidata Rave platform administration experience
Nice to Have
Bachelor's degree in mathematics, science, information systems, or related field
What You'll Do.
Administer Medidata Rave user management
Configure and maintain study environments
Handle production participant access
Serve as point of contact for EDC access
Maintain and update user access records
Perform study archiving activities
Handle database access workflows
Coordinate EDC administration timelines
Provide operational support for inspection readiness
Support database development operational meetings
Deliver training on EDC administration standards
Contribute to process improvements
Contribute to SOP development
Contribute to platform upgrades
Contribute to system integration projects
How You'll Work.
Team & Collaboration
CRO partners; Cross-functional stakeholders; Clinical Data Management teams; Cross-functional teams; Virtual team environments
Full Job Description
**About Regeneron** Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, as well as redefining our understanding of health. As a **Senior Specialist, EDC Administration** , you will support and lead EDC system administration activities across Regeneron’s clinical trial portfolio. You will serve as a key operational resource responsible for Medidata Rave administration, user access management, study environment setup, and ongoing platform support while collaborating with CRO partners and cross-functional stakeholders to ensure compliant and efficient clinical data operations. **This position is office-based and will be on site at Regeneron’s Hyderabad office.** **A typical day may include the following:** * Administer Medidata Rave user management activities including user account setup, role assignments, access provisioning, modifications, and deactivations * Configure and maintain study environments and handle production participant access within Medidata Cloud Administration * Serve as the main point of contact for EDC access-related queries from internal teams and CRO partners * Maintain and update user access records, reports, dashboards, and operational metrics across the study portfolio * Perform study archiving activities and handle database access workflows across EDC, SharePoint, and other clinical data systems * Coordinate EDC administration timelines, breakthroughs, environment setup deadlines, and release readiness activities * Provide operational support for inspection readiness activities, audit trails, and compliance documentation related to EDC administration * Partner with Clinical Data Management teams and CROs to support database
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