Principal Specialist, Clinical Data Management

Summary

Principal Specialist overseeing clinical data management for pharmaceutical studies, responsible for database lock coordination, CRO performance monitoring, and ensuring quality control and audit procedures meet departmental standards. The role requires running data review listings, coding medical history and adverse event data using MedDRA, coding concomitant medications using WHO Drug dictionaries, and collaborating with database programmers to ensure CDISC/SDTM compliance. Requires 8+ years of pharma industry experience (or equivalent with advanced degree), strong knowledge of Good Clinical Data Management Practices, and demonstrated ability to lead and manage teams across multiple projects.