"Alerted.org

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