As part of the Clinical Affairs department, the Clinical Scientist mission is to design, lead and monitor the clinical trials aimed to establish the clinical performance of our IVD Microbiology products, in respect with the Good Clinical Practices and the applicable Regulations. Position Summary: In order to maintain and uphold our products to the highest standards, the Clinical Scientist will manage clinical breakpoint evaluations by contributing to the design, preparation and analysis of data gathered from previous clinical trials. Final deliverables will correspond to the central piece of the regulatory submissions and approval processes of the products performance. He/she will balance between a highly regulated environment within strong project constraints to meet company objectives. In this context, the following activities will have to be performed:
Prepare, analyze, and review previous clinical trial data with new committee breakpoints to evaluate product performance
Provide technical reviews, data summary packages, and contribute to all project deliverables, including documentation readiness
Work with appropriate project team members in writing rationale for data acceptability for new breakpoint evaluation performed on original clinical trial data
Initiate and monitor VITEK AST clinical trials, additional testing and data collection when necessary
Prepare Summary Reports and data packages to aid in submission to regulatory bodies (e.g. FDA) and participate in interactive submission reviews
Participate and conduct the review and approval of the plans, Technical Reviews and Design Review Minutes as necessary while maintaining files for audits and completeness
Manage a Clinical Affairs Element Team composed of Clinical Data Manager, Laboratory Technician and other Clinical Scientists when necessary
Interact with internal (project team) and external interfaces (Physician, Biologist, Clinical Research Coordinator, Laboratory Technicians)
Train other team members as needed on the breakpoint evaluation process and tools
Qualifications :
Ph.D. or MS in a scientific field; MD/PharmD preferred. All ideally completed by biomedical research methodology skills. Associate to Bachelor’s degrees supplemented by at least 3 years of experience and/or appropriate internal training and/or external qualification in the field is also considered.
Breakpoint Evaluation experience preferred
Problem solving and analytical thinking skills required
Demonstrated written and oral communication skills
Key experience including: Regulatory compliance, clinical trials, data analysis and document preparation
Strong team orientation and collaboration to work with peers, investigators, and other team members that contribute to the success of the projects
Adaptable and flexible to adjust to changing demands, timelines, deliverables and/or regulations
