Job Description: The Senior RAVE Clinical Database Programmer participates in the design, development, validation, and maintenance of clinical study databases. This individual applies advanced knowledge of CRF design, database configuration, edit check programming, custom programming, reporting, system integrations, and CDMS functionality while partnering closely with Clinical Data Management and cross-functional study teams to support successful clinical trial execution.
Key Responsibilities: - Serve as the primary owner of study-specific database design within the CDMS (e.g., Medidata Rave; experience preferred), leading clinical database programming activities across multiple studies of complex design.
- Review database specification documents created by study teams, including CRF Specifications and Data Validation Specifications (DVS).
- Build clinical study database CRF screens based on approved CRF Specifications.
- Program edit checks, special actions/functions, custom programs, and derivations in accordance with the DVS.
- Plan and coordinate edit check test script development, programming, validation, and User Acceptance Testing (UAT) activities. Ensure issues are resolved in a timely manner and produce validation documentation for study teams and the Trial Master File (TMF).
- Complete study database updates in accordance with Change Request documentation and procedures, including performing impact analyses and risk assessments for proposed changes.
- Lead and support database migration activities, including live study updates and database maintenance.
- Partner with Clinical Data Management, Clinical Operations, Biostatistics, and external vendors to coordinate clinical database programming activities and ensure alignment with study timelines and objectives.
- Participate in project meetings, contribute to problem-solving discussions, communicate project risks, and proactively escalate issues that may impact timelines, scope, or quality.
- Balance multiple study assignments while effectively managing priorities and communicating resource needs.
- Troubleshoot and resolve study build, system integration (e.g., IVRS, CTMS), and change request issues using the appropriate applications.
- Develop advanced custom programs and functionality as required by study specifications.
- Ensure high-quality deliverables by reviewing study-level, program-level, and multi-study core deliverables for accuracy, completeness, and compliance.
- Participate in departmental initiatives, user group meetings, and knowledge-sharing activities to promote best practices and awareness of new system features.
- Develop detailed study execution plans, including programming, testing, and UAT milestones, providing clear visibility into study startup progress and key deliverables.
- Support the ongoing evolution of internal EDC capabilities by serving as a technical resource to cross-functional study teams and helping establish efficient database programming processes.
