Sr Mgr EDC Development

Role Summary

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.

Skills

• Ability to balance standards with protocol nuances to craft dependable Rave builds.
• Clear guidance of CRO partners while maintaining consistent practices.
• Value compliance—familiarity with 21 CFR Part 11, ICH-GCP, and CDISC standards for data collection.
• Ability to move between strategy, oversight, and hands-on configuration.
• Experience coaching developers and contributing to a high-quality global library.

Qualifications

• Required: 8+ years of EDC development experience in biotechnology, pharmaceutical, or health-related industries.
• Required: 3+ years of people-management experience.
• Required: Medidata Rave experience with thorough knowledge of Data Management and Clinical Database Development processes and applicable regulations (21 CFR Part 11, ICH-GCP, CDISC) for data collection.
• Preferred: Medidata Builder Certification.
• Preferred: C# programming knowledge.
• Preferred: TrialGrid familiarity.
• Preferred: Experience with Rave Amendment Manager and Medidata Cloud Administration.

Education

• Bachelor’s degree in mathematics, science, or a related field is required.