Clinical Trial Manager
Core
Operational execution of US and EU clinical trials for a voice-based Software as a Medical Device detecting worsening heart failure, including FDA pivotal trials and European MDR investigations.
Role type
Senior Clinical Trial Manager (Sponsor-side, no CRO)
Builds
FDA pivotal trial (15+ sites), randomized pragmatic trial, European MDR investigations
Domain
Digital cardiology / Software as a Medical Device (SaMD)
Deliverable
production ML models
Required skills
US FDA-regulated device trials, IRB submission lifecycle, multicenter trial management (sponsor-side), monitoring strategy execution, study budget and risk management, eTMF/EDC systems, regulatory compliance (21 CFR, ICH-GCP, ISO 14155, HIPAA), SOP/WI authoring
Preferred skills
Cardiology or heart failure trials, pragmatic/health-system-embedded trials, contribution to De Novo/510(k)/PMA evidence packages, advanced academic degree
Technologies
EDC, eTMF
Responsibilities
Lead trial start-up (site selection, agreements, budgets, IRB submissions, initiation, training); 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, deviations); Ensure audit/inspection readiness (FDA BIMO, IRB); Support European investigations and regulatory compliance; Author and maintain SOPs and work instructions
Seniority
Senior, hands-on IC