Data Manager
Core
Lead clinical data management operations for implantable device studies, overseeing CRO activities and ensuring data quality for regulatory submissions.
Role type
Management-level Clinical Data Manager
Builds
Clinical study data packages, regulatory submissions, and safety reports for implantable device studies
Domain
Biotechnology / Medical Devices (Implantable)
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
Clinical data management, CRO oversight, SAS, Python, advanced Excel (Power Query), data quality monitoring, query management, protocol deviation assessment
Preferred skills
Implantable device studies, Class III medical devices, regulatory submissions, protocol amendments
Technologies
SAS, Python, Excel, Power Query
Responsibilities
Oversee CRO data management activities and review deliverables; Generate clinical data reports, listings, and summaries; Fulfill ad hoc data requests and analyses; Monitor data quality and database readiness; Coordinate data cleaning and query management with vendors; Support resolution of quality issues affecting compliance
Seniority
Management, hands-on leadership