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. bioMérieux’s global headquarters is located in Marcy L’Étoile, France, and we have more than 11,200 team members in 44 countries. With our distributor network, we serve more than 160 countries. bioMérieux, Inc. sponsors public health initiatives and partnerships to address antimicrobial resistance, sepsis awareness, food safety, and consumer health. Our passionate team members recognize the power of diagnostics and rally behind our mission to help save lives.
As a Clinical Scientist 2, you will manage multiple projects of increasing complexity through design, preparation, and conduct of clinical studies in multiple trial sites, which final deliverables correspond to the central piece of regulatory submissions and approval processes. You will balance between a highly regulated environment within strong project constraints to meet company objectives. In this role, you will be consulted by others on issues related to their field of competence.
- Leads clinical projects through the definition and respect of timelines and costs, as well as the compliance with quality rules and regulations.
- Pilots projects with external and internal interfaces, notably the CA (Clinical Affairs) element team that may include teams of Clinical Scientists and/or Consultants.
- Contribute to the follow up of operational CROs related activities.
- Prepares clinical trials including developing trial strategies in regards to the registrations’ requirements, designing studies and writing plans and protocols, selecting and qualifying sites, negotiating contracts and budgets in collaboration with the purchasing department and 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 DM.
- Conducts and monitors clinical trials, coordinates all contacts with the sites/investigators in connection with the project team.
- Coordinates periodical review data and analysis, problem solving and troubleshooting.
- Writes the clinical trial reports and maintains clinical trial files.
- Prepares and leads technical reviews to launch and close trails as well as prepares posters and publications in collaboration with PI, and presents poster or oral communication in international congresses.
- Contributes to project as a project team member representing CA. May influence project team’s decisions.
- Exposed to competent and regulatory bodies (e.g. FDA) for interactive submission reviews and negotiation purposes.
- May assume other transversal CA related missions and pilots global (EU and US) functional excellence departmental activities.
Studies, Experience, Skills and Qualifications:
- MS/Engineer or Ph.D in a scientific field or MD/Pharma D or equivalent, ideally completed by biomedical research methodology skills.
- Associates to Bachelor’s Degree supplemented by solid experience and/or appropriate internal training and/or external qualification in field.
- 5+ years industry experience ideally 3 of which in IVD product development clinical trials. Sole post-doc experience with clinical exposure or a MD/PharmaD clinical research centric internship
- Technical skills in the corresponding areas: trail design methodology, scientific field, and project oriented.
- Problem solving, judgement and analytical skills.
- Ability to build relationships and teamwork/collaboration skills.
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.