Senior Clinical Research Scientist, Salt Lake City

Senior Clinical Research Scientist

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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 supervision

Contributes to the development of the study synopsis

Leads 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 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

Manages the 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

Responsible for the assessment of processes and establishing plans for improvements with limited to no supervision

Manages IIR study execution / follow-up with little to no supervision

Define and management of 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 or leads peer-reviewed journal publication of study results in collaboration with internal stakeholders

Works independently with limited to no supervision

Experience

Bachelor's degree in a life science field (biology, chemistry, medical/clinical laboratory technologist etc.) required
- Master's or PhD preferred
8+ 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 complexity
- Experience with the management of timelines, deliverables, and milestones
- Experience with budget oversight, risk mitigation, and clinical data review
- Proven track record of writing clinical study synopses, plans and study protocols
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.)

Knowledge, Skills & Abilities

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

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Location:: Salt Lake City

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