Description

The Senior Clinical Research Scientist leads the execution of health outcomes research evidence strategies that demonstrate the real-world impact, value, and clinical utility of our diagnostic solutions. This individual will play a critical role in generating data on patient outcomes, healthcare resource utilization, and cost-effectiveness to support market access, clinical adoption, and policy engagement. The ideal candidate will have experience designing and interpreting retrospective and prospective studies, working cross-functionally with medical affairs, market access, HEOR, and commercial teams

 

The Senior Clinical Research Scientist 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.

 

Primary Duties

Contributes to the development and leads the implementation of the study strategy with internal stakeholders with limited to no supervisionContributes to the development of the study synopsisLeads the development of study plan for non-registrational studies (Simple & Complex)Leads the development of BIR/CIR study protocols in collaboration with internal stakeholders for Simple and Complex studiesReview IIR study protocolsLead site selection activitiesServe 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 studiesFunctionally responsible for all clinical monitoring activities throughout studyManages the clinical study agreementsManages the coordination of logistics and training needed to execute studiesOutline and communicate safety issues and planned mitigations in collaboration with internal stakeholdersAssures clear external/internal team communication, process documentation, and compliance with BMX and departmental processes along with GCPResponsible for the assessment of processes and establishing plans for improvements with limited to no supervisionManages IIR study execution / follow-up with little to no supervision Define and management of study budgetAccountable for the delivery of documentation to meet study milestonesCoordinates the creation of the study database/CRF and reviews data/analysis with cross-functional teamsContributes to or leads the development of study abstract and/or poster in collaboration with internal stakeholdersContributes to or leads peer-reviewed journal publication of study results in collaboration with internal stakeholdersWorks independently with limited to no supervision

 

Experience

Bachelor's degree in a life science field (biology, chemistry, medical/clinical laboratory technologist etc.) requiredMaster's or PhD preferred8+ 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 with high complexityExperience with the management of timelines, deliverables, and milestonesExperience with budget oversight, risk mitigation, and clinical data reviewProven track record of writing clinical study synopses, plans and study protocolsUnderstands 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.)

 

Knowledge, Skills & Abilities

Strong computer skills including word processing and use of spreadsheets.  Skills with database and project management software desirable.Excellent communication skillsAbility to build, manage, and maintain high performing clinical studies in a fast-paced, dynamic, and global environmentAbility to operate and lead efficiently in a heavily matrixed and multi-site organizational structureStrong prioritization and decision-making skills

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BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).