Clinical Trial Scientist

Job Title: Clinical Development Scientist / Clinical Trial Scientist

Location: Bothell, WA 98021 / Cambridge, MA 02141 / Plymouth, MN 55442

Duration: 11 Months

Job Description:

• You have acquired 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.
• You have deep expertise including innovative clinical trial design, registries, quality improvement initiatives, and creation of data networks and working knowledge of biostatistics.
• Your skills include a demonstrated working knowledge of GCP, FDA regulations and EU-MDR regulations, and in-depth understanding of product development and associated design controls for medical devices.
• You have strong writing skills to product quality clinical documents, including final reports.
• Strong knowledge and experience with study design is also desired. You have an ability to write original scientific documentation such as clinical study reports, regulatory filings, investigator brochures, clinical evaluation reports, internal reports and scientific publications.