Sr Specialist, Clinical Development
Core
Ensures product development includes necessary clinical input and manages the lifecycle of complex medical device projects, specifically for transcatheter heart valves.
Role type
Senior Clinical Development Specialist (Medical Devices)
Builds
Transcatheter Heart Valve (THV) devices and related clinical evidence
Domain
Medical Devices / Cardiovascular / Clinical Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical study design, Pre-clinical test strategy, First-in-man evaluation, Clinical Investigator Brochure creation, Clinical trial strategy, Post-market evaluation, Clinical design control, Regulatory compliance (US/international), Literature review, Data evaluation
Preferred skills
Engineering background, Pre-clinical testing protocols, Hospital environments, Sterile techniques, US/international medical device regulations, GLP, GCP
Technologies
Microsoft Office Suite, Adobe
Responsibilities
Develop and implement pre-clinical test strategies, Design and conduct first-in-man product evaluations, Create Clinical Investigator Brochures, Develop clinical trial strategies, Conduct post-market evaluations, Review and update clinical design control documents, Consult with field trial managers for regulatory compliance
Seniority
Senior, hands-on IC