What are the responsibilities and job description for the Clinical Development Scientist position at ONI Infotech?
Hi,
We have an urgent job opening for Clinical Development Scientist____ Bothell WA, Cambridge MA, or Plymouth MN (On-Site)___Please send the updated resume if you find comfortable for this position.
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
Citizenship:-USC or Green Card
Client:-Philips
Job Description:-
Responsible for developing, generating, and disseminating clinical and economic evidence ensuring innovation, and transformation with best-in-class clinical evidence.
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 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. 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
Duties:
- 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.
- 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.
Rajnish Kumar
Sr. Technical recruiter
ONI Infotech, LLC
Phone:-507-268-6230
Rajnish.@oniinfotech.com
Address-16191 Coastal Highway, Lewes Delaware 19958
Website: www.oniinfotech.com
