Senior Manager, Clinical Data Management
Core
Lead clinical data management (CDM) strategy, execution, and staffing for multiple clinical trials and post-marketing surveillance projects in the trans catheter heart valve (THV) business unit.
Role type
Senior Manager, Clinical Data Management
Builds
Clinical trial data deliverables, data management plans (DMPs), standard operating procedures (SOPs), and project timelines for THV devices.
Domain
Medical Devices / Structural Heart / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical Data Management (CDM) strategy, project management, team leadership, regulatory policy application, data discrepancy investigation, stakeholder communication, process improvement, EDC system expertise, Microsoft Office Suite (advanced Excel), documentation, training development.
Preferred skills
N/A
Technologies
EDC systems, Microsoft Office Suite
Responsibilities
Manage a small team of CDM SMEs; plan and lead multi-site/multi-cohort data management activities; develop DMPs, SOPs, and work instructions; identify and resolve data discrepancies by liaising with clinicians; provide guidance to CRAs and PMS staff; consult on CDM project sections; provide leadership to outsourcing partners.
Seniority
Senior, hands-on IC with team management
