Senior Manager, Clinical Operations
Core
Leading clinical trial operations for central sleep apnea therapies, managing site recruitment, protocol development, and regulatory compliance for medical device trials.
Role type
Senior Manager, Clinical Operations (Medical Devices)
Builds
Clinical trial programs for sleep apnea therapies
Domain
Medical Devices / Clinical Research / Sleep Medicine
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial management, team leadership, regulatory compliance (ICH-GCP), budget management, stakeholder coordination, risk-based monitoring, site activation, protocol development
Preferred skills
Cardiology or sleep medicine experience, Premarket Approval (PMA) device experience, advanced degree
Technologies
CTMS, EDC, eTMF
Responsibilities
Lead clinical trial operational execution including site identification and recruitment; Develop clinical study protocols and supporting documentation; Manage internal teams, CROs, and vendors; Ensure compliance with regulatory requirements and internal SOPs; Manage study budgets and timelines; Lead cross-functional team meetings and provide updates to senior leadership; Conduct performance reviews and manage team development.
Seniority
Senior, hands-on IC with people management
