A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions that detect disease and contamination to improve patient health and ensure consumer safety. In North America we have more than 5,000 team members across 12 sites or subsidiaries, including Salt Lake City based BioFire Diagnostics. We believe in the power of diagnostics and bioMérieux sponsors public health initiatives and partnerships to address antimicrobial resistance, sepsis awareness, food safety, and consumer health across the globe. Come be a part of our mission to help save lives.
The Clinical Scientist manages clinical projects through design, preparation and conduct of clinical studies in multiple trial sites, which final deliverables correspond to the central piece of the regulatory submissions and approval processes. He/she balances between a highly regulated environment within strong project constraints to meet company objectives:
- Leads clinical projects through the definition and respect of timelines and costs, as well as the compliance with quality rules and regulations. Pilots projects external and internal interfaces, notably the CA element team.
- 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.
- Conducts and monitors clinical trials, coordinates all contacts with the sites/investigators, in connection with project team. Coordinates periodical data review and analysis, problem solving and trouble shootings.
- Writes the clinical trial reports, maintains clinical trial files. Prepares and leads technical reviews to launch and close trials. Prepares posters and publications, in collaboration with Principal Investigator.
- Contributes to project as project team member representing Clinical Affairs.
- Contributes to the preparation of interactive submission reviews with competent and regulatory bodies (e.g. FDA…).
Studies, Experience, Skills and Qualifications:
- 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 3+ years industry experience is expected.
- Technical skills in the corresponding area (trial design methodology, scientific field)
- Project management oriented.
- Problem Solving/Judgment/Analytical Thinking.
- Relationship building/Teamwork and Collaboration
Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture. Our Group offers numerous possibilities: so come and join the 11,200 bioMérieux team members who already identify with these values!
bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.