Manager EDC Administration
Regeneron
Hyderabad, Telangana, India
Full-Time
Competitive
OfficeManager
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.
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
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
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 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.