"Alerted.org

The Senior 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 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