EDC Programmer

About CG Oncology, Inc. Are you ready to make a difference in the world and become part of our patient-centered team that is focused on Attacking Bladder Cancer for a Better Tomorrow? At CG Oncology, we believe that by having exceptionally talented individuals on our team who share our passion and enjoy working together, we can truly achieve our Vision and Mission to benefit patients around the world. Every day we are making significant advancements across our multiple pipelines and are growing rapidly to meet the needs of our patients who cannot afford to wait to benefit from our novel immunotherapies. Please review this job posting and our Values and if they resonate with you and are what you expect from your organization and team, then we would like to hear from you. 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 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. 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 Please note that CG Oncology does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Any resumes or client information submitted to our careers page or any employee of CG Oncology by any search firm or agency without an applicable contract in place will become the property of CG Oncology and no fee(s) will be paid. Total Rewards CG Oncology offers very competitive and comprehensive Total Rewards, helping to support and reward our global team of high-performing employees focused on developing bladder-saving therapeutics for patients afflicted with bladder cancer. HIGHLY COMPETITIVE SALARIES ANNUAL PERFORMANCE/MERIT REVIEWS ANNUAL PERFORMANCE BONUSES EQUITY SPECIAL RECOGNITION Well-Being Benefits In addition to our Total Rewards, CG Oncology offers a variety of Well-Being Benefits to meet the majority of the needs of our unique and growing workforce. These benefits are designed to support our team to achieve a healthy balance between work and their personal lives to remain refreshed, engaged, and creating an environment where each person can find a deeper meaning and purpose in their work. Well-Being Benefits eligibility begins the 1st of the month after hire. While a majority of these benefits are for our US-based workforce, we continue to assess comparable levels of benefits for our international team members that are aligned with country-specific regulations and their national programs offered. 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 CG Oncology is an Equal Opportunity Employer: All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. At CG Oncology, we are building a community of intelligent and passionate team members that share our Vision, Mission and Values, and while the biotechnology space can feel limited in BIPOC, non-binary and even female representation, we endeavor to make hiring decisions that will continue to grow and support our team in the direction of maintaining cultural diversity and sustainability.