Senior Manager EDC Development

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

• Acting as an escalation point for complex technical, operational, and stakeholder challenges

This job may be for you if you have:

• Extensive experience with Medidata Rave, including database design, edit check programming, and platform administration

• Strong expertise in EDC development, UAT methodologies, and quality management processes

• Solid understanding of regulatory requirements including 21 CFR Part 11, ICH-GCP, and CDISC standards

• Proven leadership experience leading teams and driving performance in a matrix environment

• Experience handling CRO/vendor relationships and ensuring high-quality deliverables

• Strong strategic thinking, problem-solving, and stakeholder management skills

• Ability to influence without authority and collaborate effectively with senior leadership and cross-functional teams

• Good to have Medidata Builder Certification, TrialGrid experience and Exposure to programming (e.g., C#)

To be considered for this role, you must have:

• Bachelor’s degree in mathematics, science, information systems, or a related field (advanced degree preferred)

• 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

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location.  In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.  For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together.  For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
 

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions.  For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process.  Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.