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.
As part of the Global 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 immuno-assays, in respect with the Good Clinical Practices and the applicable Regulations.
In this context, the following activities will have to be performed:
- Design the clinical trials and write the associated clinical trial plan and protocols, in association with the key members of the project team such as R&D and biostatisticians,
- Manage a Clinical Affairs Element Team composed of Clinical Data Manager, Laboratory Technician and other Clinical Scientists when necessary,
- Prepare and update regularly the clinical trial budget,
- Prepare and update the clinical trial schedule using project management software,
- Prepare the ethical/regulatory submissions required for the clinical trials (IRB…),
- Identify and qualify the clinical trials sites,
- Initiate the clinical trial sites and monitor the progress of the study as defined in the monitoring plan,
- Interact with internal (project team) and external interfaces (Physician, Biologist, Clinical Research Coordinator, Laboratory Technicians),
- Review the clinical data and report the intermediate and final results to the project team,
- Write the clinical trial report and provide inputs for the product package insert,
- Archive all the trial related documents
- Master’s degree or higher in Biological Science
- 2 years industry (IVD/medical device) experience preferred
- Immunoassays experience preferred
- Experience in clinical lab with some clinical trial exposure preferred
- Problem solving and analytical thinking skills required,
- Demonstrated written and oral communication in English,
- Technical skills in the corresponding area (trial design methodology, scientific field),
- Strong team orientation and collaboration to work with peers, investigators, and other team members that contribute to the success of the clinical trials,
- Adaptable and flexible to adjust to changing demands, timelines and deliverables,
- Travel required up to 15%,
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 13,000 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.