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ema-regulations jobs in San Diego

$158,100 – $216,000 · Posted 1 month ago

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.… 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.

San DiegoLast seen 1 month ago