Manager, Clinical Data Review – Medical Devices (on-site)
Core
Lead a team responsible for managing all data related to clinical studies, ensuring database integrity, and delivering clean datasets for analysis in medical device clinical trials.
Role type
Manager, Clinical Data Review (Team Lead)
Builds
Clinical study datasets and reports for analysis
Domain
Medical Devices / Clinical Trials
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Team leadership and staff development, Data management (entry, cleaning, deliverables), CRF design and edit check specifications, Data quality assurance and integrity checks, Regulatory compliance (FDA), Process optimization, Stakeholder communication
Preferred skills
Enterprise/cross-division business unit experience
Technologies
Oracle Clinical
Responsibilities
Hire, retain, coach, and mentor a diverse data management staff; Manage data entry, cleaning, and deliverables; Oversee CRF development and edit check specifications; Ensure data integrity through quality checks and protocol compliance; Manage custom reporting requests from clinical databases; Stay current on regulatory requirements and train staff on changes.
Seniority
Manager, hands-on leadership with team accountability