EDC Programmer

About the role

The EDC Programmer is responsible for the design, development, validation, and maintenance of electronic data capture (EDC) systems to support clinical trials. This role ensures high-quality, compliant data collection through robust database builds in Medidata Rave EDC and Zelta (Merative) platforms. The EDC Programmer partners cross-functionally with Data Management, Biostatistics, Clinical Operations, and external vendors to support study execution, data integrity, and regulatory requirements.

Essential Functions

• Deliver high-quality, fully validated EDC database builds aligned to protocol and standards
• Develop and maintain edit checks, derivations, and custom functions in Rave and Zelta
• Ensure timely database go-live and updates to support study timelines
• Support database lock activities and data cleaning workflows
• Establish strong cross-functional collaboration with DM, Biostats, and clinical teams
• Ensure compliance with CDISC standards, regulatory expectations, and internal SOPs
• Design, build, and validate clinical trial databases in Medidata Rave EDC and Zelta (Merative)
• Develop CRFs, edit checks, derivations, and custom functions per protocol and data specifications
• Review and interpret protocols, SAPs, and data transfer specifications to support database design
• Perform UAT support, issue resolution, and system enhancements
• Ensure all EDC builds adhere to CDISC (SDTM) standards, data standards, and regulatory compliance
• Collaborate cross-functionally with Data Management, Biostatistics, Clinical Operations, and medical teams
• Support data cleaning activities, including discrepancy management and query logic optimization
• Manage and oversee database changes, migrations, and version control
• Interface with external vendors (e.g., CROs such as PFM/KMK) and manage deliverables as needed
• Contribute to process improvements, standards development, and system optimization initiatives
• Maintain inspection readiness through proper documentation, traceability, and validation records
• Oversee and execute user access governance for Medidata Rave and Zelta EDC platforms, including user provisioning, role assignment, and deprovisioning aligned with study responsibilities; ensure compliance with GCP, 21 CFR Part 11, and internal SOPs, maintain inspection-ready audit trails, partner with Data Management, Clinical Operations, and QA for access approvals, and lead periodic user access reviews and reconciliation activities to ensure system integrity and data security.

Qualifications

• Bachelor's or Master's degree in Computer Science, Life Sciences, or related field
• 5+ years of EDC programming experience in pharmaceutical or biotech setting
• Hands-on experience with: Medidata Rave EDC (architect, edit checks, custom functions), Zelta (Merative) EDC platform
• Strong understanding of clinical trial processes and data flow
• Experience working with CDISC standards (SDTM preferred)
• Experience supporting database validation and UAT activities
• Prior CRO/vendor collaboration experience preferred

Total Rewards

• HIGHLY COMPETITIVE SALARIES
• ANNUAL PERFORMANCE/MERIT REVIEWS
• ANNUAL PERFORMANCE BONUSES
• EQUITY
• SPECIAL RECOGNITION
• Well-Being Benefits

Full details about Total Rewards and Well-Being Benefits can be found in the "About CG Oncology" section.