What are the responsibilities and job description for the Clinical Development Scientist position at VetForce Solutions?
Job Details
Job Title: Clinical Development Scientist
Location: -Bothell WA, Cambridge MA, or Plymouth MN
(MUST be located near one of these sites already. Not looking for someone who needs to relocate)
Duration: -Long term Contract
Skills/Education:
PHD or MD candidate with a Scientist background.
MUST HAVE worked in the medical device space who has designed studies for regulatory environments.
Reporting protocols experience within this industry also required.
US Regulations experience is required and China NPA would be highly desired
7 years of experience in clinical research/development/real world evidence (RWE); scientific study design, strong scientific background and experience with Artificial Intelligence algorithm clinical performance validation.
Expertise including innovative clinical trial design, registries, quality improvement initiatives, and creation of data networks and working knowledge of biostatistics.
Demonstrated working knowledge of Google Cloud Platform, FDA regulations and EU-MDR regulations, and in-depth understanding of product development and associated design controls for medical devices.
Strong writing skills to product quality clinical documents, including final reports. Strong knowledge and experience with study design is also desired.
Ability to write original scientific documentation such as clinical study reports, regulatory filings, investigator brochures, clinical evaluation reports, internal reports and scientific publications.
Travel up to 15% (domestic and international) according to business needs
