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.
In order to maintain and uphold our products to the highest standards, the Clinical Scientist will manage clinical studies by contributing to the design, preparation and analysis of data gathered in 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:
- Leads clinical projects with respect of timelines and costs, as well as the compliance with quality rules and regulations.
- Prepares clinical trials, including designing studies and writing plans and protocols, selecting and qualifying sites, negotiating contracts and budgets in collaboration with purchasing department, setting up, equipping and training sites.
- Develops the monitoring strategy and contributes to the definition of the clinical trial data workflow by collaboratively working with data management.
- Provide technical reviews, data summary packages, and contribute to all project deliverables, including documentation readiness.
- 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)
- May require up to 10-15% travel
- Ph.D. or MS/Engineer in a scientific field; MD/PharmD or equivalent; All ideally completed by biomedical research methodology skills. Associate to Bachelor’s degrees supplemented by a solid experience and/or appropriate internal training and/or external qualification in the field is also considered.
- Ideally 5+ years industry experience preferred
- Project management oriented.
- 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