Specialist, EDC User Acceptance Testing, Quality Control & Development

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Specialist, EDC Development and UAT to join our Data Management team in a hybrid role. In this role, you will perform EDC database development, User Acceptance Testing, and Quality Control for assigned clinical studies, ensuring Database Development functions meet Regeneron procedures, clinical data standards, and SOPs, while collaborating with CRO Clinical Database Developers and Clinical Data Management. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

Hyderabad, India (hybrid)

Discover your role:

• Build early to late phase studies in Medidata Rave, then program edit checks, dynamics, derivations, and custom functions in Rave Architect

• Configure study setup, including user administration, AE/SAE alerts, IRT accounts, and Coder registration

• Run UAT end-to-end — from UAT Plan and site setup through test scripts, execution, and sign-off

• Track, triage, and resolve UAT issues through to go-live

• Conduct Quality Control on internal and CRO builds, covering eCRF design, edit checks, derivations, custom functions, and integrations

• Document QC findings, verify corrections, and improve QC checklists, procedures, and UAT templates

• Manage post-production changes through Rave Amendment Manager and support third-party integrations such as IxRS and labs

• You bring a quality-focused mindset and strong attention to detail in resolving system defects

This role requires:

• Bachelor's degree in mathematics, science, or a related field

• 2+ years of EDC development experience in biotech, pharmaceutical, or healthcare

• Medidata Rave experience required

• Strong understanding of UAT methodologies, test script development, and defect management

• Knowledge of 21 CFR Part 11, ICH-GCP, and CDISC standards

• Robust knowledge of Data Management and Database Development processes

• Strong cross-functional collaboration and time management in a matrix environment

• UAT coordination or execution and QC of EDC systems strongly preferred

• Medidata Builder Certification, C# programming, or TrialGrid knowledge a plus