Senior Manager, Data Management
Core
Lead end-to-end clinical data management activities across Phase II and III studies to ensure data accuracy, completeness, and inspection readiness.
Role type
Senior Manager, Clinical Data Management
Builds
Clinical study databases, data management plans, and regulatory documentation for biotechnology/pharmaceutical development programs.
Domain
Biotechnology / Clinical Research
Required skills
Clinical data management strategy, EDC system development, RTSM/IWRS configuration, CDISC standards (CDASH/SDTM), FDA/ICH-GCP/21 CFR Part 11 compliance, data cleaning and reconciliation, team mentorship, project management.
Preferred skills
EDC Designer certification, eCOA/ePRO experience, medical coding, safety systems, data visualization tools.
Technologies
EDC systems, RTSM, IRT, IWRS, eCRF, Data Warehouses.
Responsibilities
Oversee study-level data management activities and external vendors; lead core processes including eCRF design, edit checks, and database lock; translate protocols into data collection tools; mentor junior team members; ensure TMF documentation and inspection readiness.
Seniority
Senior, hands-on IC with leadership responsibilities
