Senior Clinical Research Scientist
Core
Organize and conduct clinical performance evaluations for new products and enhancements, serving as a clinical resource on product development teams to assess device performance and patient safety.
Role type
Senior Clinical Research Scientist (Device Evaluation)
Builds
Clinical performance evaluation plans, device Instructions for Use (IFU), and post-market clinical evaluations for medical devices.
Domain
Healthcare / Medical Devices / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical study protocol development, clinical trial design, analysis and interpretation, regulatory agency submission document creation, literature review and summarization, risk analysis for new devices, collaboration with biostatistics and data management, bench testing and in-vitro/in-vivo device evaluations, manufacturing and quality input.
Preferred skills
Master's Degree in Biological Science.
Technologies
Pubmed, integrated referencing software.
Responsibilities
Develop clinical study protocols and trial designs; create scientifically sound documents for regulatory submissions; evaluate new product ideas via literature review; perform risk analysis for new or improved devices; write device Instructions for Use (IFU); support bench testing and device evaluations; coordinate post-market clinical evaluations; conduct Health Risk Assessments.
Seniority
Senior, hands-on IC