Note: The job is a remote job and is open to candidates in USA. CG Oncology, Inc. is focused on attacking bladder cancer through innovative immunotherapies. The EDC Programmer will design, develop, validate, and maintain electronic data capture systems to support clinical trials, ensuring compliance and high-quality data collection.
Responsibilities
- 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
- Participate in database lock activities, ensuring quality and completeness of data
- 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
Skills
- 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 supporting database validation and UAT activities
- Experience working with CDISC standards (SDTM preferred)
- Prior CRO/vendor collaboration experience preferred
Benefits
- ANNUAL PERFORMANCE/MERIT REVIEWS
- ANNUAL PERFORMANCE BONUSES
- EQUITY
- SPECIAL RECOGNITION
- FULLY REMOTE WORK ENVIRONMENT
- REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off
- HOLIDAYS –In 2026 we will observe 14 holidays
- RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary
- HEALTH (MEDICAL, DENTAL, VISION) – PPO & HDHP – Cigna/Principal
- HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC
- ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans
- LIFE INSURANCE – Company Paid 2 x base salary + Voluntary Plans
- ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More
- Well-Being Benefits eligibility begins the 1st of the month after hire.
Company Overview