What are the responsibilities and job description for the Clinical Development Scientist position at Careers Integrated Resources Inc?
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.
Responsibilities
- 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, being agile and responsive during the course of design, execution, and interpretation of trial data.
- Collaborate with investigators, IRBs/ECs, Regulatory Agencies, societies, and associations 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 the process of clinical evidence generated for marketing authorization, in line extensions, including during sponsor regulatory inspections.
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.
