Senior Manager, EDC Development

Overview We’re growing our Clinical Database Development team, and we’re looking for a thoughtful leader to help us deliver reliable, inspection‑ready EDC solutions that support our key development programs. We provide clear direction, consistent processes across studies, and caring mentorship so our developers and CRO partners can do their best work. We champion quality standards and regulatory requirements, and we celebrate practical, elegant builds in Medidata Rave. We’ll support you as you guide strategy, develop talent, and shape the standards that move our portfolio forward! Responsibilities Oversee CRO EDC database builds and ensure process compliance. Build and configure Rave studies using our Global Library. Program edit checks, dynamics, derivations, and custom functions. Lead UAT setup in Cloud Administration and drive resolution to go‑live. Configure Coder, TSDV, and Clinical Views as protocols require. Manage amendments, migrations, and quick publishes with Rave tools. Qualifications & Attributes Balance standards with protocol nuances to craft dependable Rave builds. Guide CRO partners with clarity while maintaining consistent practices. Value compliance—21 CFR Part 11, ICH‑GCP, and CDISC are second nature. Move comfortably between strategy, oversight, and hands‑on configuration. Enjoy coaching developers and contributing to a high‑quality global library. To Be Considered A bachelor’s degree in mathematics, science, or a related field is required, along with 8+ years of EDC development experience in biotechnology, pharmaceutical, or health‑related industries and 3+ years of people‑management experience. Medidata Rave experience is required, and you bring thorough knowledge of Data Management and Clinical Database Development processes and of applicable regulations ( 21 CFR Part 11, ICH‑GCP, CDISC standards for data collection). Preferred qualifications include Medidata Builder Certification , C# programming knowledge, and TrialGrid familiarity, plus experience with Rave Amendment Manager and Medidata Cloud Administration. Salary Range $134,400.00 - $219,200.00 Equal Opportunity & On-site Information 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. 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, please visit the official total rewards page. For other countries’ specific benefits, please speak to your recruiter. 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. #J-18808-Ljbffr