Regeneron is hiring for the position of Specialist, EDC Administration in Hyderabad. This opportunity is suitable for experienced professionals with a background in clinical data management, EDC administration, clinical systems administration, or related pharmaceutical and biotechnology operations.
The Regeneron EDC Administration Specialist will support electronic data capture systems across the company’s clinical trial portfolio. The position primarily involves Medidata Rave administration, user access management, study environment configuration, EDC system compliance, archiving, and cross-functional coordination.
Candidates should have at least 3+ years of experience in the biotechnology, pharmaceutical, healthcare, or related industry, including a minimum of 2 years of direct EDC or clinical systems administration experience. Hands-on Medidata Rave platform administration experience is required.
Key Responsibilities
As a Specialist, EDC Administration at Regeneron, the selected candidate will:
- Administer Medidata Rave User Management activities for assigned clinical studies.
- Set up and maintain user accounts, roles, permissions, and production participant access.
- Manage access requests, modifications, and user deactivations through established workflows.
- Perform administrative activities using Medidata Cloud Administration.
- Maintain accurate records and reports of user access across EDC systems.
- Serve as a point of contact for EDC access-related queries from internal teams and CRO partners.
- Perform study archiving activities.
- Administer database access interfaces for EDC, SharePoint, and other data systems according to approved request workflows.
- File data management documents from legacy studies into the Trial Master File (TMF).
- Coordinate the EDC Administration calendar and track important study milestones.
- Track environment setup deadlines, access provisioning timelines, and go-live readiness checkpoints.
- Participate in Database Development operational meetings with Data Management CRO partners.
- Support special projects involving platform upgrades, system migrations, and integrations.
- Support inspection-readiness activities involving EDC administration, access audit trails, and compliance documentation.
- Collaborate with Clinical Data Management, CRO partners, and other cross-functional stakeholders.
Qualification & Eligibility
Candidates interested in the Regeneron Specialist EDC Administration job in Hyderabad should meet the following requirements:
Education: Bachelor’s degree in Mathematics, Science, Information Systems, or a related field.
Experience: Minimum 3+ years of experience in the biotechnology, pharmaceutical, healthcare, or related industry, including at least 2 years of direct EDC administration or clinical systems administration experience.
Candidates should also possess:
- Hands-on Medidata Rave experience, which is required for this position.
- Knowledge of Rave Cloud Administration and User Management.
- Experience with EDC environment configuration.
- Knowledge of Medidata Rave PDF Generator.
- Understanding of clinical data management processes.
- Knowledge of 21 CFR Part 11 requirements.
- Understanding of ICH-GCP Guidelines.
- Knowledge of CDISC standards relevant to clinical data collection.
- Understanding of user access control principles and audit trail requirements.
- Knowledge of system compliance within regulated clinical environments.
- Experience with user access management is strongly preferred.
- Study environment configuration experience is strongly preferred.
- Ability to coordinate with virtual and cross-functional teams.
- Strong written and verbal communication skills.
- Ability to manage multiple clinical studies and competing priorities.
- Proficiency with SharePoint, Microsoft Office, and collaboration tools.
Key Skills
Medidata Rave, EDC Administration, Clinical Data Management, Rave Cloud Administration, Rave User Management, Clinical Systems Administration, User Access Management, EDC Environment Configuration, 21 CFR Part 11, ICH-GCP, CDISC, Audit Trails, TMF, SharePoint, Clinical Trials, Database Administration, CRO Management and Inspection Readiness.
Experience Required
This is not primarily a fresher-level opportunity.
Regeneron specifically requires:
3+ years of biotechnology, pharmaceutical, healthcare, or related industry experience, including at least 2 years of direct EDC administration or clinical systems administration experience.
In addition, Medidata Rave platform administration experience is required.
Professionals currently working in Clinical Data Management, EDC Administration, Clinical Systems, Database Development, or related clinical technology functions may find this role particularly relevant.
Why Join Regeneron?
Regeneron offers employees the opportunity to work within a global biotechnology organization supporting clinical research and drug development.
Depending on country, position, and eligibility, the company’s total rewards package may include:
- Annual bonuses or other incentive programs
- Equity awards where applicable
- Retirement or pension benefits
- Health and wellness programs
- Insurance benefits
- Paid time off
- Family support benefits
- Professional development opportunities
Specific compensation and benefits applicable to the Hyderabad position will be communicated during the recruitment process.
How to Apply
