Scientist, Clinical Research
Core
Provides scientific expertise throughout the development and implementation of clinical studies, clinical evaluations, or risk management for medical devices and diagnostics.
Role type
Senior Clinical Research Scientist
Builds
Clinical study protocols, evaluation plans, risk master lists, and scientific publications for regulatory submissions and new product applications.
Domain
Healthcare / Clinical Research / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial protocol design and management, regulatory agency interaction, scientific literature evaluation, data analysis for clinical studies, project timeline and budget management, site selection coordination, audit support, risk management, cross-functional team leadership, Phase I-IV study result interpretation
Preferred skills
None stated
Technologies
None stated
Responsibilities
Write and manage clinical trial protocols, protocol amendments, and informed consents; facilitate communication between Sales, Marketing, R&D, Regulatory Affairs, and external CROs; conduct site selection meetings and manage final site lists; create and manage clinical study timelines and budgets; interpret Phase I to IV clinical study results for new product applications; present scientific data at industry and regulatory meetings; provide progress reports to Institutional Review Boards and Medical Ethics Committees; participate in audits.
Seniority
Senior, hands-on IC