onsite
Senior EDC Programmer - Cytel
Software Engineer
Senior EDC Programmer responsible for designing, developing, and maintaining clinical databases in Medidata Rave, translating protocol requirements into robust EDC solutions, and ensuring regulatory compliance across clinical trials.
About the role
Key Responsibilities
- Design, develop, and maintain clinical databases using Medidata Rave, ensuring alignment with protocol specifications.
- Create and validate CRFs, edit checks, derivations, and data integration logic to support accurate data capture.
- Collaborate with data management, biostatistics, and clinical teams to troubleshoot issues and optimize database performance.
- Ensure all database builds comply with regulatory standards (FDA, EMA, ICH) and industry best practices.
- Document database specifications, change requests, and validation reports for audit readiness.
Requirements
- Extensive experience (5+ years) in Medidata Rave database development and maintenance.
- Strong knowledge of clinical trial data structures, CRF design, and regulatory requirements.
- Proficiency in SQL and data integration techniques within the Medidata environment.
- Excellent problem‑solving skills and attention to detail in a fast‑paced clinical setting.
- Effective communication skills for cross‑functional collaboration.
Skills
software developmentsystem designproblem solving