Regeneron

Healthcare

SeniorManagerEDCDevelopment

₹35–55L ~AI est. Hyderabad, India FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Manager candidates.

The Brief

“Senior Manager EDC Development at Regeneron. Skills: EDC Development, UAT, People Management. Lead clinical database development. Lead User Acceptance Testing (UAT) activities”

Industry & Context.

Healthcare
Problems you'll solve

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

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