Clinical Scientist

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For more than 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 45 countries and serve 160 countries with the support of a large distribution network.
Come and join a family-owned global company with a long-term vision, and a human-centered culture.

Reporting to the Clinical Affairs department, you will coordinate, design, monitor and interpret clinical studies designed to establish the biological performance of our in vitro diagnostic devices in Immunoassays, in compliance with good clinical practice and current regulations.

Your main tasks will be to :

- Develop methodology and write study plans and protocols in collaboration with the project team (in particular R&D and Data Science)

- Coordinate actions within Clinical Affairs and communication with clinical study sites

- Remote and on-site monitoring of study site activities to ensure study compliance

- Providing logistical, technical, and regulatory support to both BioMérieux and study site personnel to ensure that all parties have the necessary equipment, training, and materials to fulfill their role in the studies

- Maintain study tracking documents and contribute to study procedures and final study reports

- Real-time monitoring/management of site inventory/supplies to ensure sufficient resources are available to avoid study interruptions

- Coordinate shipping and receiving of specimens from study sites to the internal laboratory team or other external reference laboratories, as needed

- Coordinate with Data Specialists/Managers to resolve data discrepancies, initiate queries, and ensure sites act promptly to address them, as needed

- May participate in scientific conferences and contribute to scientific journals

- Maintain current knowledge of IHC/Good Clinical Practices and maintain current training in Human Subjects Protections through an accredited program (e.g. CITI)

- Supervise and train interns.

Who are you?

- Bachelor degree in biology with at least 2 years' experience in the scientific field, ideally in the IVD industry.

- Experience in a biology laboratory with exposure to clinical research is desirable. A background and experience in immunoassays would be a plus.

- Excellent interpersonal skills and the ability work with a wide variety of people (physicians, laboratory directors, laboratory staff, etc.) involved in conducting the clinical studies.

- The ability to work closely with Clinical Research Scientist to identify and communicate areas of technical, schedule, and budget risk

- Excellent written and oral communication skills are essential

- Strong computer skills required including word processing and use of spreadsheets. Skills with database and project management software desirable.

- Demonstrated ability to independently manage projects and report areas of risk as they arise.

- Excellent organizational skills

- You speak and write fluent English. 

bioMérieux welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.