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. Your role: Contribute strategic guidance for clinical and economic evidence related to the end to end (E2E) development process from ideation through post-market for products in the Ultrasound business.
location: Bothell, Washington
job type: Contract
salary: $85.00 - 94.78 per hour
work hours: 9 to 5
education: Doctorate
responsibilities:
- Collaborate with key internal and external stakeholders to provide in-depth expertise to develop and lead clinical initiatives through non-clinical and clinical strategies for new product development initiatives and product life cycle management.
- Drive execution ensuring quality and timeliness of clinical programs and/or trials to support critical regulatory requirements, be agile and responsive during course of design, execution, and interpretation of trial data.
- Collaborate with investigators, IRBs/ECs, Regulatory Agencies, societies, and associations; and additionally, to support claims, reimbursement, health economic outcomes and/or market access.
- Ensure appropriate preparation, interpretation and dissemination of all evidence generated, including Clinical Study Reports (CSRs), Clinical Evaluation Reports (CERs), abstracts, peer-reviewed manuscripts, as assigned.
- Lead or support scientific discussions with regulatory agencies or notified bodies, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, in line extensions, including during sponsor regulatory inspections.
qualifications:
Required
- PhD or MD with a science background
- 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.
- 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.
- Strong writing skills to product quality clinical documents, including final reports.
- Travel up to 15% (domestic and international) according to business needs.
- Strong knowledge and experience with study design
- An ability to write original scientific documentation such as clinical study reports, regulatory filings, investigator brochures, clinical evaluation reports, internal reports and scientific publications.
- Present statistical methods and results to a variety of audiences, especially non-statisticians.
skills: FDA, CSR, GCP (Good Clinical Practice), Clinical Study Design
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
