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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.