Regeneron
Healthcare
SeniorManagerEDCDevelopment
Neural analysis suggests this role is
optimal for Manager candidates.
“Senior Manager EDC Development at Regeneron. Skills: EDC Development, UAT, People Management. Lead clinical database development. Lead User Acceptance Testing (UAT) activities”
Industry & Context.
Problem-solving; Troubleshooting
What They're Looking For.
Must Have
Bachelor's degree in mathematics, science, information systems, or a related field, Minimum of 8+ years of experience in biotechnology, pharmaceutical, or healthcare industry, At least 4+ years of direct EDC development experience, Minimum 3+ years of people management experience, Proven experience leading UAT and QC functions for EDC systems, Experience building governance frameworks, SOPs, and driving process improvements in regulated environments
Nice to Have
Advanced degree preferred, Medidata Builder Certification, TrialGrid experience, Exposure to programming (e. g. , C#)
What You'll Do.
Lead clinical database development
Lead User Acceptance Testing (UAT) activities
Ensure high-quality EDC system delivery
Drive standardization across EDC processes
Drive innovation across EDC processes
Drive continuous improvement across EDC processes
Lead and develop a team
Oversee resource planning
Oversee workload allocation
Oversee capacity management
Drive end-to-end EDC database development
Manage database build
Manage edit check programming
Manage post-production change management
Provide oversight of UAT activities
Manage defect management
Manage release readiness assessments
Establish UAT standards
Establish UAT templates
Establish quality benchmarks
Partner with cross-functional teams
Ensure alignment on database development strategy
Ensure alignment on quality results
Drive innovation by evaluating new EDC technologies
Drive innovation by implementing new EDC technologies
Drive innovation by evaluating automation tools
Drive innovation by implementing automation tools
Lead process standardization
Lead continuous improvement initiatives
Act as escalation point for technical challenges
Act as escalation point for operational challenges
Act as escalation point for stakeholder challenges
How You'll Work.
Team & Collaboration
Cross-functional team members; Senior leadership
Communication Scope
Performance management; Career development
Process & Methodology
Resource planning, Workload allocation, Capacity management
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 Manager, EDC Development & UAT, you will lead Clinical Database Development and User Acceptance Testing (UAT) activities across the global clinical trial portfolio. You will be responsible for ensuring high-quality, compliant EDC system delivery from design through release and post-production, while driving standardization, innovation, and continuous improvement across EDC processes. **This position is office-based and will be on site at Regeneron’s Hyderabad office.** **A typical day may include the following:** * Leading and developing a team of Managers and specialists across EDC Development, UAT, and QC functions, including performance management and career development * Overseeing resource planning, workload allocation, and capacity management across a global portfolio * Driving end-to-end EDC database development, including eCRF design, database build, edit check programming, and post-production change management * Providing oversight of UAT activities including planning, execution, defect management, and release readiness assessments * Establishing UAT standards, templates, and quality benchmarks to ensure consistency across internal and CRO-delivered systems * Partnering with CROs and cross-functional team members to ensure alignment on database development strategy and quality results * Driving innovation by evaluating and implementing new EDC technologies and automation tools * Leading SOP development, process standardization, and continuous improvement initiatives across EDC Development and UAT functions
Applying for this Senior Manager EDC Development role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Regeneron?
Real rants from real employees. Read before you apply.