Clinical Trial Manager
Core
Own operational execution of US FDA pivotal trial and randomized pragmatic trial for a voice-based heart failure detection device, while overseeing European MDR investigations.
Role type
Senior Clinical Trial Manager (Sponsor-side, no CRO)
Builds
FDA-cleared Software as a Medical Device (SaMD) for heart failure monitoring
Domain
Digital cardiology / FDA-regulated medical devices
Deliverable
production ML models
Required skills
US FDA-regulated device trials, IRB submission lifecycle, multicenter trial start-up to close, monitoring strategy execution, study budget management, audit/inspection readiness, SOP/WI authoring
Preferred skills
Cardiology or heart failure trials, pragmatic/health-system-embedded trials, De Novo/510(k)/PMA evidence packages, advanced academic degree
Technologies
EDC, eTMF
Responsibilities
Lead trial start-up including site selection, agreements, budgets, and IRB submissions; Drive enrollment and protocol adherence across sites; Own monitoring strategy and conduct remote/on-site monitoring visits; Manage study budgets, timelines, and risk registers; Run operational backbone (eTMF, EDC, data cleaning, protocol deviations); Ensure audit and inspection readiness (FDA BIMO, IRB); Support European investigations and regulatory compliance (ISO 14155, MDR); Author and maintain SOPs and work instructions
Seniority
Senior, hands-on IC
