Website Integrated Resources, Inc
Integrated Resources, Inc
Company : Integrated Resources, Inc
Job Title: Clinical Development Scientist
Location: Hybrid: This is a hybrid role. 3 days/week in office (Bothell or Cambridge locations). open to candidates in Plymouth (MN) as well.
Duration: 11 Months+
Pay range: $80 -90/hr. on w2
Job Description:
Ultrasound, Senior Clinical Development Scientist the Senior Clinical Development Scientist for the Ultrasound group will be responsible for developing, generating, and disseminating clinical and economic evidence ensuring innovation, and transformation with best-in-class clinical evidence.
Required Qualifications
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.
Deep expertise including innovative clinical trial design, registries, quality improvement initiatives, and creation of data networks and working knowledge of biostatistics.
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.
Strong writing skills to produce quality clinical documents, including final reports.
Ability to write original scientific documentation such as clinical study reports, regulatory filings, investigator brochures, clinical evaluation reports, internal reports, and scientific publications.
Medical or scientific education (MD or PhD).
Ability to successfully perform the minimum Physical, Cognitive, and Environmental job requirements with or without accommodation for this clinical position.
Self-directed with a strong work ethic, agile, and able to work in a purposeful environment.
Ability to collaborate effectively and influence decision-making with various teams cross-functionally, as well as externally.
Analytical thinking skills, with the ability to present statistical methods and results to a variety of audiences, especially non-statisticians.
Ability to travel up to 15% (domestic and international) according to business needs.
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