Manager Clinical Affairs
Core
Manage clinical operations professionals and oversee clinical trial startup, site closure, and lifecycle activities for medical devices.
Role type
Manager, Clinical Affairs (Sponsor-side)
Builds
Clinical trials for medical devices
Domain
Medical Technology / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical operations management, Study lifecycle management, Site activation and closeout, Regulatory compliance (GCP), Stakeholder relationship management, Process improvement, Risk mitigation, Cross-functional collaboration, Protocol and study document development, Clinical monitoring oversight
Preferred skills
Advanced degree in Life Sciences or Nursing, Sponsor-side clinical operations experience, Clinical monitoring experience
Technologies
GCP, Case Report Forms (CRF), Study Protocols
Responsibilities
Coordinate and oversee clinical trial startup and site closure activities; Prepare and manage end-to-end study documentation including contracts, budgets, and regulatory submissions; Collaborate with cross-functional teams (R&D, RA, Quality) to ensure adherence to regulations and study timelines; Lead identification and implementation of standardized processes and process improvements; Monitor clinical trial safety and data consistency with protocols.
Seniority
Manager, hands-on leadership
