Manager EDC Administration

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.

This role is responsible for leading EDC system administration activities across Regeneron’s global clinical trial portfolio. You will ensure efficient, compliant, and scalable administration of the Medidata Rave platform, while driving operational excellence, governance, and team leadership within the EDC function.

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 EDC Administration professionals, providing coaching, feedback, and performance management

Driving resource planning and workload allocation to ensure timely delivery of EDC administration activities

Managing EDC environments, including user access provisioning, role assignment, and deactivation within Medidata platforms

Ensuring compliance with governance frameworks, access controls, and regulatory standards

Partnering with cross-functional teams (Database Developers, Study Data Managers) for study setup, build, UAT, and go-live activities

Supporting clinical database development activities including Rave setup, user administration, alert configuration, and system integrations

Monitoring KPIs and operational metrics to improve team performance and delivery outcomes

Contributing to SOPs, work instructions, and continuous improvement initiatives

Driving inspection readiness and ensuring alignment with quality and regulatory requirements

This job may be for you if you have:

Strong expertise in EDC administration, including Medidata Rave (Cloud Administration, user management, environment configuration)

Proven experience leading and developing teams in a matrix environment

Deep understanding of clinical data management processes and cross-functional workflows

Knowledge of regulatory frameworks including 21 CFR Part 11 and ICH-GCP guidelines

Ability to drive process improvements, governance, and operational excellence

Strong problem-solving, project management, and stakeholder management skills

Excellent communication skills with the ability to influence and collaborate across teams

To be considered for this role, you must have:

Bachelor’s degree in mathematics, science, information systems, or a related field

Minimum of 7+ years of experience in biotechnology, pharmaceutical, or healthcare industry

At least 4+ years of direct experience in EDC or clinical systems administration

Prior people management or team lead experience preferred

Experience in establishing governance frameworks, SOPs, and processes in a regulated environment

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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. If you have any questions, please speak with your recruiter.

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 on‑site. Please speak with your recruiter and hiring manager for more information about on‑site 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.