cdisc-standards jobs in San Diego

The Clinical Data Manager will oversee data management activities for clinical trials, ensuring compliance with protocols, industry standards, and regulations. Responsibilities include managing Case Report Forms (CRF), Electronic Data Capture (EDC) systems, data review strategies, database lock coordination, and cross-functional collaboration with Clinical Operations, Biostatistics, CROs, and vendors.…See more The role requires 2+ years of clinical data management experience, a bachelor's degree in a medical or scientific field, and proficiency with clinical data entry systems, CDISC standards, ICH guidelines, and FDA regulations.

Sr. Principal Specialist will oversee clinical database programming operations, including review/cleaning programs, validation procedures, database migrations, SAS dataset creation, and vendor management within a pharmaceutical environment.…See more The role requires hands-on technical expertise in Medidata Rave, SAS, and SQL alongside strategic leadership of cross-functional teams and oversight of regulatory compliance, inspection readiness, and system implementations. Responsibilities include proactive risk mitigation, evaluation and adoption of new technologies, and acting as a technical liaison across Clinical Data Management, Clinical Operations, Regulatory, and IT. The ideal candidate combines 8+ years of clinical database programming experience (or equivalent with advanced degree) with expert knowledge of CDISC standards, GCP regulations, and end-to-end drug development processes.