Principal Specialist, Clinical Data Mgmt
Core
Leads and performs clinical data management for First-In-Human (FIH) studies, ensuring high-quality data for regulatory submissions and safety reporting.
Role type
Principal Specialist, Clinical Data Management (IC with leadership)
Builds
Clinical databases and data packages for FIH studies
Domain
Biopharmaceuticals / Clinical Data Management
Required skills
Clinical data management, eCRF design, database lock, MedDRA coding, WHO Drug coding, CDISC/SDTM standards, GCP compliance, SAS, SQL, Medidata Rave Architect, SOP development, vendor management, team leadership
Preferred skills
Business Objects, Rave Targeted SDV, Batch Uploader, C# programming
Technologies
SAS, SQL, Medidata Rave Architect, Business Objects, MedDRA, WHO Drug, CDISC/SDTM
Responsibilities
Lead data management for FIH studies including protocol review and eCRF design; perform hands-on data cleaning, QC, and database lock; collaborate with Biometrics, Safety, and Clinical Ops; develop SOPs and train staff; manage CRO performance and timelines; run data review listings and issue queries.
Seniority
Principal, hands-on IC with team leadership