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Clinical Scientist

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Location: Saint Louis, United States
Position Type: Unfixed Term
Job Function: Clinical Affairs

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

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

 

Qualifications :

  • Master’s degree or higher in Biological Science preferred.  Will consider a Bachelor's Degree in Biological Science with 4-5 years of experience. 
  • 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.

 

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BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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