Specialist, EDC User Acceptance Testing, Quality Control & Development

Job description

**Roles & Responsibilities:** - Build early to late phase studies in Medidata Rave, then program edit checks, dynamics, derivations, and custom functions in Rave Architect - Configure study setup, including user administration, AE/SAE alerts, IRT accounts, and Coder registration - Run UAT end-to-end from UAT Plan and site setup through test scripts, execution, and sign-off - Track, triage, and resolve UAT issues through to go-live - Conduct Quality Control on internal and CRO builds, covering eCRF design, edit checks, derivations, custom functions, and integrations - Document QC findings, verify corrections, and improve QC checklists, procedures, and UAT templates - Manage post-production changes through Rave Amendment Manager and support third-party integrations such as IxRS and labs - You bring a quality-focused mindset and strong attention to detail in resolving system defects **This role requires:** - Bachelor's degree in mathematics, science, or a related field - 2+ years of EDC development experience in biotech, pharmaceutical, or healthcare - Medidata Rave experience required - Strong understanding of UAT methodologies, test script development, and defect management - Knowledge of 21 CFR Part 11, ICH-GCP, and CDISC standards - Robust knowledge of Data Management and Database Development processes - Strong cross-functional collaboration and time management in a matrix environment - UAT coordination or execution and QC of EDC systems strongly preferred - Medidata Builder Certification, C# programming, or TrialGrid knowledge a plus