Senior Manager, Data Management
Core
Lead and manage data management activities for clinical trials across all phases of development, ensuring database design, validation, and review in compliance with regulatory standards.
Role type
Senior Manager, Clinical Data Management
Builds
Clinical trial databases, SDTM datasets, and data review tools for neuroscience drug candidates
Domain
Biopharmaceuticals / Clinical Development / Neuroscience
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial database design, Database validation, Data review, Vendor management (CROs), CDISC standards, EDC systems, Adverse event coding, Protocol review for consistency
Preferred skills
CNS disease area experience, Pediatric rare disease experience, e-diary database design, Safety laboratory data management
Technologies
EDC systems, CDISC standards, SDTM
Responsibilities
Design clinical trial databases including CRF development and data review tools; Oversee external data management vendors regarding KPIs, timelines, and budgets; Optimize data collection activities by reviewing protocols for cross-trial consistency; Maintain knowledge of Health Authority regulations and competitive trends; Propose and maintain Standard Operating Procedures for the department
Seniority
Senior Manager, hands-on leadership
