Specialist, EDC Administration

The Specialist, EDC Administration, under limited supervision, leads and performs EDC system administration activities across the Regeneron clinical trial portfolio. Serves as a key operational resource responsible for Medidata Rave environment setup, user access management, and platform administration. Works collaboratively with CRO partners, Clinical Data Management, and cross-functional stakeholders to ensure EDC administrative functions are performed accurately, and in compliance with Regeneron procedures, SOPs, and regulatory requirements. Job Duties: User Access Management & Administration Administer Rave User Management activities for assigned studies: Set up and maintain user accounts, roles, and permissions in Medidata Cloud Administration; manage production participant access; process access requests, modifications, and deactivations based on established workflows. Maintain and update records/reports of user access across EDC systems. Serve as a point of contact for EDC access-related queries from internal teams and CRO partners. Escalate issues to supervisors or senior team members as appropriate. Operational Support & Process Management Perform archiving activities for assigned studies Directly administer the database access interface based on request form workflows (EDC, SharePoint, other data systems) File data management documents from legacy studies into the Trial Master File Maintain and update records/reports of users’ access Attend events and record project team output as assigned Coordinate and manage the EDC Administration calendar, tracking key milestones across studies (environment setup deadlines, access provisioning timelines, go-live readiness checkpoints). Cross-Functional Collaboration & Training Contribute to Database Development operational meetings with DM CRO partners, representing EDC administration topics. Contribute to special projects requiring EDC administration input, including platform upgrades, migrations, and system integrations. Support inspection readiness activities related to EDC system administration, user access audit trails, and platform compliance documentation. Job Requirements: ·        Medidata Rave experience is required, with knowledge of Rave administration functions (Cloud Administration, User Management, environment configuration, PDF Generator). ·        Demonstrates working understanding of all applicable regulations including 21 CFR Part 11, ICH-GCP Guidelines, and CDISC standards for data collection. ·        Demonstrates robust knowledge of Data Management processes and EDC platform administration best practices. ·        Demonstrates strong understanding of access control principles, audit trail requirements, and system compliance in a regulated clinical environment. ·        Ability to work effectively with virtual teams in a matrix environment. ·        Strong understanding of cross-functional activities and stakeholder coordination. ·        Strong ability to manage multiple and varied tasks with enthusiasm; prioritize workload with attention to detail. ·        Effective time management to meet objectives across multiple concurrent studies. ·        Excellent interpersonal, oral, and written communication skills. ·        Proficiency with SharePoint, Microsoft Office Suite, and collaboration tools. ·        Ability to adjust in a fast-paced environment.

Minimum of 3+ years of experience in biotechnology, pharmaceutical, or health-related industry with a minimum of 2 years of direct EDC administration or clinical systems administration experience. Experience with Medidata Rave platform administration is required. Prior experience in user access management and study environment configuration is strongly preferred.

Bachelor's degree in mathematics, science, information systems, or related field. Does this sound like you? Apply now