EDC Programmer

Role: EDC Programmer responsible for designing, developing, validating, and maintaining electronic data capture systems to support clinical trials in bladder cancer. Responsibilities: build and validate high-quality, compliant EDC databases (Medidata Rave and Zelta), develop edit checks and custom functions, support database lock, and ensure data integrity and regulatory compliance. Collaborates cross-functionally with Data Management, Biostatistics, Clinical Operations, and external vendors. Ensures adherence to CDISC standards, 21 CFR Part 11, and internal SOPs. Manages user access governance and audit trails to maintain inspection readiness. Requirements: Bachelor's or Master's in Computer Science, Life Sciences, or related field; 5+ years of EDC programming experience in pharma/biotech; proficiency with Medidata Rave and Zelta platforms; understanding of clinical trial processes, data flow, and CDISC standards. Preferred: experience supporting validation and UAT, CRO/vendor collaboration. High-value: focus on clinical trials in bladder cancer, electronic data systems, GxP compliance, and cross-functional collaboration in a remote work environment.