Clinical Data Management Manager
Core
Lead Clinical Data Management (CDM) activities to ensure accurate and timely acquisition, analysis, and reporting of diverse clinical data for drug discovery, development, and marketed products.
Role type
Senior Clinical Data Management Manager
Builds
Clinical study databases and regulatory submission data packages for HIV, viral hepatitis, COVID-19, and cancer therapies
Domain
Biopharmaceuticals / Clinical Trials
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CDM process design, CRF/eCRF design, vendor oversight, regulatory compliance (FDA/EMA), data quality assurance, project management, risk management, training and mentoring
Preferred skills
Data analytics, leading small projects, understanding product development goals, advanced knowledge of web-based EDC systems, process improvement initiatives
Technologies
CRF/eCRF systems, web-based EDC systems, CDM systems
Responsibilities
Lead CDM activities for complex studies; review study protocols; identify and resolve CDM queries; act as point of contact for study management; ensure data completeness and accuracy; lead CDM process design with vendors; support regulatory submissions and audit responses; train and mentor colleagues
Seniority
Senior, hands-on IC with leadership responsibilities
