Senior Specialist, EDC Administration

As a Senior Specialist, EDC Administration, you will support and lead EDC system administration activities across Regeneron’s clinical trial portfolio. You will serve as a key operational resource responsible for Medidata Rave administration, user access management, study environment setup, and ongoing platform support while collaborating with CRO partners and cross-functional stakeholders to ensure compliant and efficient clinical data operations.

This position is office-based and will be on site at Regeneron’s Hyderabad office.

A typical day may include the following:

• Administer Medidata Rave user management activities including user account setup, role assignments, access provisioning, modifications, and deactivations

• Configure and maintain study environments and handle production participant access within Medidata Cloud Administration

• Serve as the main point of contact for EDC access-related queries from internal teams and CRO partners

• Maintain and update user access records, reports, dashboards, and operational metrics across the study portfolio

• Perform study archiving activities and handle database access workflows across EDC, SharePoint, and other clinical data systems

• Coordinate EDC administration timelines, breakthroughs, environment setup deadlines, and release readiness activities

• Provide operational support for inspection readiness activities, audit trails, and compliance documentation related to EDC administration

• Partner with Clinical Data Management teams and CROs to support database development operational meetings and issue resolution

• Deliver training and mentorship on EDC administration standards, Medidata platform capabilities, and access management workflows

• Contribute to process improvements, SOP development, platform upgrades, migrations, and system integration projects

This job may be for you if you have:

• Strong expertise in Medidata Rave administration including Cloud Administration, User Management, environment configuration, and PDF Generator

• Knowledge of clinical data management processes and EDC platform administration standards

• Understanding of 21 CFR Part 11, ICH-GCP Guidelines, and CDISC standards in regulated clinical environments

• Solid understanding of access controls, audit trail requirements, and compliance documentation

• Excellent interpersonal skills with the ability to handle high-volume operational tasks accurately and efficiently

• Good communication, problem-solving, and stakeholder management skills

• Ability to work effectively in cross-functional and virtual team environments

• Experience developing and improving operational workflows and standard processes

• Strong time management skills with the ability to manage multiple concurrent studies and priorities

• Proficiency with SharePoint, Microsoft Office Suite, and collaboration tools

To be considered for this role, you must have a minimum of 4+ years of experience in the biotechnology, pharmaceutical, or healthcare industry, including at least 2 years of direct EDC administration or clinical systems administration experience. Experience with Medidata Rave platform administration is required. A bachelor’s degree in mathematics, science, information systems, or a related field is preferred.

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.