Senior Clinical Research Scientist H/F - bioMérieux

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 46 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.We are looking for a Senior Clinical Research Scientist who will work and grow within the Medical Evidence Generation department and will report to Director, Clinical Research Scientists, in a team of five co-workers.

The position is offered under a fixed-term contract of 11 months and is based in Marcy L'Etoile - with travels across France (~5%) and international (~5%).


What will your responsibilities be?
You lead the execution of the clinical studies that make up the company's clinical evidence generation program. In this role, you will execute clinical studies and/or programs worldwide in accordance with strategy, project plans, approved budget and resource allocations following applicable regulatory and standard operating procedures.

You collaborate closely with cross-functional teams, including Medical Scientists, Biostatistics & Data Management, Medical Writers, and Marketing to generate impactful clinical evidence that supports the company's strategy. This role is crucial in maintaining our commitment to scientific excellence and patient-centric approaches within the competitive global healthcare landscape.

Your main missions will be the following:
* 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
* Lead the development of study plan for non-registrational studies (Simple & Complex)
* Lead the development of BIR/CIR study protocols in collaboration with internal stakeholders for Simple and Complex studies
* Review IIR study protocols
* Lead site selection activities
* Serve as Global Medical Affairs subject matter expert with external resources and contacts at various management levels concerning clinical operations or scheduling of specific phases of clinical studies
* Functionally responsible for all clinical monitoring activities throughout study
* Manage the clinical study agreements
* Manage the coordination of logistics and training needed to execute studies
* Outline and communicate safety issues and planned mitigations in collaboration with internal stakeholders
* Assure clear external/internal team communication, process documentation, and compliance with BMX and departmental processes along with GCP
* Assess processes and establishing plans for improvements with limited to no supervision
* Manage IIR study execution / follow-up with little to no supervision
* Define and manage study budget
* 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 abstract and/or poster in collaboration with internal stakeholders
* Contribute to or lead peer-reviewed journal publication of study results in collaboration with internal stakeholders

Who are you?

* You hold a Bachelor's Degree in a life science field (biology, chemistry, medical/clinical laboratory technologist etc.).
* You bring 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 clinical studies with high complexity.
* You have demonstrated experience in managing timelines, deliverables, and study milestones, with strong prioritization and decisionmaking abilities
* You possess solid expertise in budget oversight, risk mitigation, and clinical data review.
* You have a strong understanding of both US and European medical testing environments, as well as relevant professional societies and regulatory guidelines (including FDA, CE-Mark IVD Directives, CAP, CLIA, WHO, IASLC, ASCCP, etc.).
* You have a proven ability to write clinical study synopses, clinical plans, and study protocols.
* You have strong computer skills, including proficiency with word processing and spreadsheets; experience with databases and project management software is a plus.
* You demonstrate excellent communication skills in a matrixed and multi-site organizational structure.
* You are willing to travel approximately 10% of the time.