EDC Programmer / Clinical Database Developer

We are seeking an experienced EDC Programmer / Clinical Database Developer to support the technical design, development, and delivery of clinical trial databases and systems., * Perform hands-on Medidata Rave EDC study design, development, build, testing, and implementation

• Interpret clinical study protocols and translate requirements into technical database designs and specifications
• Design and develop CRFs/eCRFs, EDC build specifications, edit checks, validation specifications, and related documentation
• Configure, program, review, and test clinical database functionality and edit checks
• Perform technical feasibility and impact assessments for database changes and protocol amendments
• Support UAT, system testing, study go-live, production support, database changes, and database lock activities
• Develop clinical databases in accordance with established data standards, including CDASH and SDTM
• Support standardized EDC libraries, templates, and study-build methodologies
• Coordinate technical deliverables across Clinical Science, Data Management, Monitoring, Biostatistics, Statistical Programming, and other study functions
• Support integration and data flow between EDC and related clinical systems such as eCOA/ePRO, IRT/IVRS/IWRS, randomization systems, and external data sources
• Track study-build timelines, deliverables, dependencies, risks, and technical issues
• Ensure clinical database development complies with applicable SOPs, GCP, ICH guidelines, regulatory requirements, and quality standards
• Identify opportunities to improve and standardize clinical systems processes
• Provide technical guidance and mentorship while remaining actively involved in hands-on EDC development

This is a hands-on technical EDC study-build role, not a people-management position. The ideal candidate will have extensive experience personally designing and building clinical studies within Medidata Rave, developing eCRFs and EDC specifications, programming/configuring edit checks, and partnering with cross-functional clinical study teams through study go-live.

Candidates whose experience is primarily focused on Clinical Data Management oversight or vendor management without direct technical EDC build experience will not be the best fit., * Bachelor’s degree in Life Sciences, Computer Science, Information Technology, Management Information Systems, or a related discipline

• 7+ years of relevant EDC/clinical database study-build experience
• Strong, recent, hands-on Medidata Rave experience
• Demonstrated experience personally designing and building EDC studies
• Experience developing eCRFs/CRFs, EDC specifications, and edit checks
• Strong understanding of CDASH and SDTM
• Experience with EDC testing, UAT, study go-live, database changes, and protocol amendments
• Strong understanding of clinical trial processes and the clinical study lifecycle
• Experience coordinating technical deliverables across cross-functional clinical study teams
• Understanding of downstream clinical systems and integrations, including eCOA/ePRO and IRT
• Strong analytical, problem-solving, communication, and organizational skills, * Approximately 8+ years of Medidata Rave experience
• Veeva EDC design/build experience
• Programming experience supporting complex EDC edit checks or custom functions
• Phase I clinical trial experience
• Experience with internal clinical study tracking/development systems
• Experience supporting external clinical data integrations
• Master’s degree or PhD
• Experience in oncology, immunology, aesthetics, or eye care is a plus; therapeutic-area experience is not a primary requirement, The strongest candidate will be a hands-on Medidata Rave EDC builder/programmer who can demonstrate direct responsibility for taking clinical study requirements from protocol interpretation * eCRF/database design * specifications * edit checks/programming * testing/UAT * study go-live and ongoing database changes.