bioMérieux, a family-owned global company with a long-term vision and human-centered culture, is looking for a Senior Clinical Research Scientist to lead the execution of clinical studies that form the company's clinical evidence generation program. You will collaborate closely with cross-functional teams to generate impactful clinical evidence supporting the company's strategy.
What You'll Do
- Contribute to the development and lead the implementation of the study strategy with internal stakeholders with limited to no supervision.
- Contribute to the development of the study synopsis and lead the development of study plans for non-registrational studies.
- Lead the development of BIR/CIR study protocols in collaboration with internal stakeholders for Simple and Complex studies and review IIR study protocols.
- Lead site selection activities and serve as the Global Medical Affairs subject matter expert with external resources.
- Functionally responsible for all clinical monitoring activities throughout the study and manage the clinical study agreements.
- Manage the coordination of logistics and training needed to execute studies and outline safety issues and planned mitigations.
- Assure clear external/internal team communication, process documentation, and compliance with GCP and company processes.
- Assess processes and establish plans for improvements with limited to no supervision and manage IIR study execution and follow-up.
- Define and manage the study budget and be accountable for the delivery of documentation to meet study milestones.
- Coordinate the creation of the study database/CRF and review data/analysis with cross-functional teams.
- Contribute to or lead the development of study abstracts, posters, and peer-reviewed journal publications in collaboration with internal stakeholders.
What We're Looking For
- Bachelor’s Degree in a life science field (biology, chemistry, medical/clinical laboratory technologist, etc.).
- 8 years of experience in conducting in vitro diagnostics and/or medical device clinical research, with responsibilities for managing all major aspects of strategic planning, organization, implementation, and delivery of highly complex clinical studies.
- Demonstrated experience in managing timelines, deliverables, and study milestones, with strong prioritization and decision‑making abilities.
- Solid expertise in budget oversight, risk mitigation, and clinical data review.
- Strong understanding of both US and European medical testing environments and relevant professional societies and regulatory guidelines (including FDA, CE-Mark IVD Directives, CAP, CLIA, WHO, IASLC, ASCCP, etc.).
- Proven ability to write clinical study synopses, clinical plans, and study protocols.
- Strong computer skills, including proficiency with word processing and spreadsheets.
- Excellent communication skills in a matrixed and multi-site organizational structure.
- Willing to travel approximately 10% of the time.
Nice to Have
- Experience with databases and project management software is a plus.
Team & Environment
You will join a team of five co-workers, working and growing within the Medical Evidence Generation department, and reporting to the Director, Clinical Research Scientists.
Work Mode
This position is onsite at our location in Marcy L’Etoile.
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.
