• Serve as Subject Matter Expert (SME) for Medidata Rave and related Medidata applications (Core Configuration, eLearning Assignment, Reporter Assignment, Local Lab, Safety Gateway, TSDV, Batch Uploader, Imaging), advising and mentoring cross-functional teams across Data Management, Statistical Programming, Clinical Operations, and external partners.
• Lead and oversee EDC database builds in Medidata Rave, including CRF design, edit checks, derivations, code lists, user roles, and integrations, ensuring alignment with protocol requirements and industry best practices.
• Maintain and govern core EDC configuration standards, reusable libraries, and study design conventions to ensure consistency, quality, and efficiency across all studies.
• Maintain and manage Cloud Admin EDC roles, ensuring appropriate access control, compliance, and standardized role usage across studies.
• Proactively communicate updates, changes, and potential impacts related to core configuration and Cloud Admin roles to internal teams and stakeholders.
• Review, assess, and interpret Medidata release notes, platform updates, revised eLearnings, and Rave reports; evaluate impact on ongoing and upcoming studies.
• Translate Medidata system updates and enhancements into clear, actionable guidance and training for study teams.
• Act as a primary liaison between key stakeholders, ensuring alignment on EDC design, build standards, timelines, and issue resolution.
• Act as a liaison between Data Management and Statistical Programming to ensure data collection strategies support downstream analysis, reporting, and regulatory submission requirements.
• Collaborate with business owners of other Medidata applications (e.g., Coder, Safety Gateway, CTMS,, eCOA, Imaging) to support integrated data workflows and a cohesive clinical data ecosystem.
• Experience with integrating non Medidata systems such as RBQM, CTMS, IRT, and data cleaning tools with Medidata.
• Provide ongoing consultation on EDC best practices, system capabilities, and process improvements to support high-quality, compliant clinical trial execution.
