We are looking for a Clinical Research Scientist who will leads 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 will collaborates 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.

What will be your missions ?

• Contributes to the development and leads the implementation of study strategy with internal stakeholders and to the development of the study synopsis,
• Leads the development of study plan for non-registrational studies (Simple) and the development of BIR/CIR study protocols for non-registrational studies (Simple),
• Review IIR study protocols, lead site selection activities,
• Serves as Global Medical Affairs point of contact with external resources and contacts at various management levels concerning clinical operations or scheduling of specific phases of clinical studies, and will be responsible for all clinical monitoring activities throughout study,
• Manages clinical study agreements, and the coordination of logistics and training needed to execute studies,
• Outline and communicate safety issues and planned mitigations in collaboration with internal stakeholders,
• Assures clear external/internal team communication, process documentation, and compliance with BMX and departmental processes along with GCP,
• Contributes to the assessment of processes and establishing plans for improvements,
• Manages IIR study execution / follow-up with little to no supervision,
• Define and manage budget.

Profile description:

Who are you ?

• Bachelor’s / Master degree or PhD in a life science field (biology, chemistry, medical/clinical laboratory technologist etc.),
• Minimum 5 years of experience 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,
• Experience with the management of timelines, deliverables, milestones, budget oversight, risk mitigation, and clinical data review,
• Understands the US and European Medical Testing environments and relevant professional societies and guidelines (e.g. FDA, CE-Mark IVD Directives, CAP, CLIA, WHO, IASLC, ASCCP, etc.),
• Proven track record of writing clinical study plans and study protocols