Manager, Clinical Data Review
Core
Lead a team responsible for managing all data related to clinical studies, ensuring data integrity, and overseeing data management activities for medical device clinical trials.
Role type
Manager, Clinical Data Management
Builds
Clinical study datasets and analysis-ready data
Domain
Medical devices / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Team leadership and staff development, Data integrity management, Risk-Based Quality Management (RBQM), CRF design and edit check specifications, Regulatory compliance (FDA), Data cleaning and validation, Cross-functional collaboration
Preferred skills
Experience in broader enterprise/cross division business unit models
Technologies
Microsoft Office, Databases, Authoring programs
Responsibilities
Hire, retain, coach, and mentor data management staff; Manage data entry, cleaning, and deliverables; Oversee CRF development and data collection requirements; Execute Risk-Based Quality Management (RBQM) activities including risk assessments and monitoring; Ensure compliance with FDA regulations and industry standards; Monitor operational performance and implement corrective actions.
Seniority
Manager, hands-on leadership
