Descrizione del lavoro
Build our future together:
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Specialist, EDC Administration to join our Data Management team in a hybrid role. In this role, you will lead EDC system administration across our clinical trial portfolio — Medidata Rave environment setup, user access management, and platform administration — while collaborating with CRO partners, Clinical Data Management, and cross-functional team members, ensuring these functions meet Regeneron procedures, SOPs, and regulatory requirements. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
When & where:
Hyderabad, India (hybrid)
Discover your role:
Administer Rave User Management — accounts, roles, and permissions in Medidata Cloud Administration
Process access requests, modifications, and deactivations across studies
Maintain user access records and respond to queries from internal teams and CRO partners
Administer the database access interface across EDC, SharePoint, and other data systems
Perform archiving and file legacy study documents into the Trial Master File
Coordinate the EDC Administration calendar across environment setup, access provisioning, and release milestones
Contribute to platform upgrades, migrations, and integrations, and support inspection readiness for access audit trails and compliance
You stay organized and detail-focused while managing multiple concurrent studies
This role requires:
Bachelor's degree in mathematics, science, information systems, or a related field
2+ years in biotech, pharmaceutical, or healthcare, with 2+ years in EDC or clinical systems administration
Medidata Rave platform administration required, including Cloud Administration, User Management, environment configuration, and PDF Generator
Strong understanding of access control, audit trails, and system compliance in a regulated environment
Knowledge of 21 CFR Part 11, ICH-GCP, and CDISC standards
Robust knowledge of Data Management processes and EDC platform administration best practices
Proficiency with SharePoint, Microsoft Office Suite, and collaboration tools
Communication, cross-functional coordination, and time management in a matrix environment
Prior user access management and study environment configuration strongly 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.