Sr Mgr EDC Development

Regeneron Pharmaceuticals • Village of Tarrytown, NY

1d • Onsite

About The Position

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! A Typical Day: 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. This Role May Be For You if you: 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.

Requirements

• A bachelor’s degree in mathematics, science, or a related field is required
• 8+ years of EDC development experience in biotechnology, pharmaceutical, or health‑related industries
• 3+ years of people‑management experience.
• Medidata Rave experience is required
• 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)

Nice To Haves

• Medidata Builder Certification
• C# programming knowledge
• TrialGrid familiarity
• experience with Rave Amendment Manager and Medidata Cloud Administration

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.

Benefits

• 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
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Manager