bioMérieux
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The Clinical Research Scientist 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.
The 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-centered approaches within the competitive global healthcare landscape.
Primary Duties
Contributes to the development and leads the implementation of study strategy with internal stakeholders
Contributes to the development of the study synopsis
Leads the development of study plan for non-registrational studies (Simple)
Leads the development of BIR/CIR study protocols for non-registrational studies (Simple)
Review IIR study protocols
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
Functionally responsible for all clinical monitoring activities throughout study
Manages clinical study agreements
Manages 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 study budget
Accountable for the delivery of documentation to meet study milestones
Coordinates the creation of the study database/CRF and reviews data/analysis with cross-functional teams
Contributes to or leads the development of study abstract and/or poster in collaboration with internal stakeholders
Contributes to peer-reviewed journal publication of study results in collaboration with internal stakeholders
All other duties as assigned.
Experience
Bachelor's degree in a life science field (biology, chemistry, medical/clinical laboratory technologist etc.) required
Master’s or PhD preferred
5+ years of experience related to 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, and milestones
Experience with 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
Knowledge, Skills & Abilities
Strong computer skills including word processing and use of spreadsheets. Skills with database and project management software desirable.
Demonstrate ability to work collaboratively with various stakeholders in a highly matrixed global environment
Seniority level Associate
Employment type Full-time
Job function Science
Industries Medical Equipment Manufacturing
Referrals increase your chances of interviewing at bioMérieux by 2x
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Get AI-powered advice on this job and more exclusive features.
Direct message the job poster from bioMérieux
The Clinical Research Scientist 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.
The 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-centered approaches within the competitive global healthcare landscape.
Primary Duties
Contributes to the development and leads the implementation of study strategy with internal stakeholders
Contributes to the development of the study synopsis
Leads the development of study plan for non-registrational studies (Simple)
Leads the development of BIR/CIR study protocols for non-registrational studies (Simple)
Review IIR study protocols
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
Functionally responsible for all clinical monitoring activities throughout study
Manages clinical study agreements
Manages 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 study budget
Accountable for the delivery of documentation to meet study milestones
Coordinates the creation of the study database/CRF and reviews data/analysis with cross-functional teams
Contributes to or leads the development of study abstract and/or poster in collaboration with internal stakeholders
Contributes to peer-reviewed journal publication of study results in collaboration with internal stakeholders
All other duties as assigned.
Experience
Bachelor's degree in a life science field (biology, chemistry, medical/clinical laboratory technologist etc.) required
Master’s or PhD preferred
5+ years of experience related to 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, and milestones
Experience with 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
Knowledge, Skills & Abilities
Strong computer skills including word processing and use of spreadsheets. Skills with database and project management software desirable.
Demonstrate ability to work collaboratively with various stakeholders in a highly matrixed global environment
Seniority level Associate
Employment type Full-time
Job function Science
Industries Medical Equipment Manufacturing
Referrals increase your chances of interviewing at bioMérieux by 2x
#J-18808-Ljbffr