Senior Clinical Scientist
Core
Design, execution, and monitoring of internal and external clinical studies for structural heart disease device solutions.
Role type
Senior Clinical Scientist (Medical Devices)
Builds
Clinical studies and data supporting product development and market introduction for structural heart devices.
Domain
Healthcare / Medical Devices / Structural Heart
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical study design, study protocol development, clinical site identification and qualification, regulatory compliance, cross-functional collaboration, risk management, physician management, safety management, external research committee interaction.
Preferred skills
Medical device clinical trial experience, TAVR trial experience, Investigational Device Exemption (IDE) trial experience.
Technologies
Clinical study management systems, regulatory databases.
Responsibilities
Develop and review departmental operating procedures; develop study protocols for experiments and result documentation; execute and monitor Abbott-sponsored external clinical studies (PMA and outcome studies); participate in clinical strategy development for product development and market introduction; manage cross-functional teams for product development including risk management.
Seniority
Senior, hands-on IC