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Presage Technologies · 3 weeks ago

Clinical Research Scientist

United States

Full-time

Remote

Mid, Senior Level

$150K/yr - $190K/yr

Presage Technologies is focused on improving healthcare quality and accessibility through innovative technology. The Clinical Research Scientist will lead the development and execution of clinical evidence for regulatory submissions, ensuring rigorous study design and collaboration with partners to meet FDA standards.

ConsultingInformation TechnologySoftware

Responsibilities

Design and justify clinical studies for regulatory submissions, including sampling frameworks, statistical power analyses, endpoints, reference methods, and population considerations

Author presubmission and scientific documentation, translating complex clinical, statistical, and technical concepts into clear, audit-ready materials for FDA and partner institutions

Develop and standardize study protocols, statistical analysis plans, and documentation templates to ensure consistency, traceability, integrity of data, and regulatory alignment across all evidence-generation activities

Lead collaboration with clinical partners and research sites, coordinating IRB submissions, site preparation, and execution of clinical and bench testing

Oversee on-site or remote study activities, including device setup, data collection workflows, operational troubleshooting, and adherence to protocol requirements

Interpret early data outputs from sensors, algorithms, and clinical studies to assess signal quality, data sufficiency, and alignment with intended use claims

Develop and communicate the scientific rationale behind study designs to internal teams, physicians, and external stakeholders, ensuring shared understanding of clinical and statistical foundations

Support human factors and usability assessments, contributing to study design, execution, and documentation of user interaction patterns and risks

Collaborate with engineering, scientific, and regulatory teams to ensure that study designs reflect product capabilities and generate evidence needed for submissions

Contribute to evidence governance, including documentation structure, data traceability, and justification narratives needed for FDA review and audit readiness

Identify high-impact opportunities to accelerate clinical validation, reduce study costs, and refine evidence strategies as the technology and regulatory landscapes evolve

Maintain flexibility to support adjacent scientific, quality, or testing initiatives, based on organizational needs and evolving clinical programs

Qualification

Clinical trial designStatistical modelingScientific writingFDA regulationsData interpretationCollaboration with IRBsHuman factors testingAnalytical skillsCommunication skillsTeamwork

Required

Experience designing or contributing to clinical trials, clinical research protocols, or regulated study frameworks

Ability to perform statistical modeling and develop defensible sample-size and power calculations

Exceptional scientific and technical writing skills (e.g., clinical protocols, presubs, scientific papers, or technical reports)

Experience collaborating with clinical partners, IRBs, or research institutions

Strong ability to interpret data from algorithms, sensors, or biomedical measurements

Experience with reviewing FDA regulations and developing proposals for clinical trials that fulfill FDA's requirements for medical device clearance. Cognizance of tools and techniques for managing the economics of such trials is highly valued

Comfortable representing the company to physician groups, external partners, and research sites

Able to work across engineering, science, and regulatory teams with clarity and initiative