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
Senior IC clinical data manager (FIH focus)
Builds
Clinical databases and data packages for regulatory submissions
Domain
Biopharmaceuticals / Clinical Data Management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical data management, GCP, CDISC/SDTM/CDASH standards, SAS, SQL, Medidata Rave Architect, database lock, query resolution, MedDRA/WHO Drug coding, vendor selection, SOP development
Preferred skills
Business Objects, Rave Targeted SDV, Batch Uploader, C# programming
Technologies
SAS, SQL, Medidata Rave Architect, Business Objects, MedDRA, WHO Drug
Responsibilities
Design eCRFs and database structures for FIH studies; perform rapid data cleaning and near real-time safety reviews; coordinate UAT and database lock activities; lead development of data management SOPs; oversee CRO performance and data management timelines; run data review listings and issue queries; code Medical History and AE data using MedDRA; collaborate with Biometrics and Safety teams on regulatory submissions.
Seniority
Senior, hands-on IC with leadership responsibilities