Specialist, EDC User Acceptance Testing, Quality Control & Development

BioSpace; Hyderabad; Hybrid; INR 900,000 - 1,500,000; Full time

Job summary

Regeneron seeks a Specialist, EDC Development and UAT to join our Data Management team in Hyderabad. You will perform EDC database development, UAT, and quality control for assigned clinical studies, ensuring adherence to Regeneron procedures, clinical data standards, and SOPs while collaborating with CROs and internal teams.

In this hybrid role, you will build study setups in Medidata Rave, program edit checks and derivations, run end-to-end UAT, track issues, and contribute to QC for eCRF

Qualifications

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

Responsibilities

• Build early to late phase studies in Medidata Rave, then program edit checks, dynamics, derivations, and custom functions.
• 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, 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.
• You bring a quality-focused mindset and strong attention to detail in resolving system defects.

Skills

EDC development

Medidata Rave

UAT

Quality Control

Test script development

CDISC standards

21 CFR Part 11

ICH-GCP

Data Management

Database Development

Cross-functional collaboration

Education

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

Tools

Medidata Builder Certification

C# programming

TrialGrid knowledge

Job description

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

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.