AI Clinical Product Researcher - UK/Hybrid Odin Vision is a multi-award-winning company that provides state-of-the-art AI-enabled software applications for endoscopic procedures. These applications aid clinicians in the detection and diagnosis of disease, supporting higher quality care, improved patient outcomes, and better value for healthcare payers. We are looking for a full-time AI Clinical Product Researcher to support the execution of clinical research activities that inform AI medical device product development, clinical performance validation, and regulatory evidence generation. The role contributes to the generation of high-quality clinical evidence by supporting study execution, data collection, analysis, and documentation under the guidance of senior team members. This full-time hybrid role requires national and international travel (UK, EU, & US) and attendance at live endoscopy procedures. Salary range - £35-45K Key Responsibilities
Clinical Research Support & Execution
Essential
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Clinical Research Support & Execution
- Support the execution of clinical research activities for AI-based medical devices, including real-world performance evaluations, usability/human factors engineering, literature reviews, pilot studies, and clinical investigations.
- Assist in the preparation and maintenance of research protocols, analysis plans, study documentation and logs.
- Conduct clinical data collection, cleaning, and analysis in line with approved study plans.
- Monitor study progress and escalate issues, deviations, or risks to senior team members as appropriate.
- Contribute to the preparation of research reports, literature reviews, and supporting documentation.
- Ensure research outputs are accurate, well-documented, and aligned with regulatory and internal quality expectations.
- Contribute content to clinical evaluation documentation and other regulatory-facing materials under guidance from senior team members.
- Collaborate with internal teams, including Clinical Research, Human Factors, AI Software Engineering, AI Medical Devices, AI Product, and AI Research & Data Science.
- Provide structured clinical input and observations to senior team members to inform product design and development discussions.
- Participate in cross-functional meetings as required to support assigned research activities.
- Support interactions with clinical investigators, trial sites, CROs, and other external research partners.
- Participate in site visits, user observations, and data collection activities as required.
- Gather structured clinician and user feedback to inform clinical research and product improvement.
- Conduct training and onboarding activities related to the use of AI-based medical devices in clinical research settings.
- Ensure that activities conducted with KOLs and research sites are within the contractual scope and are documented in accordance with internal processes.
- Conduct all activities in accordance with internal policies, external regulations, and ethical standards, and report deviations to senior leadership.
- Maintain accurate, complete, and up-to-date study documentation.
- Support ethical approval applications and amendments under guidance from senior team members.
- Contribute to continuous improvement initiatives by providing feedback on processes, templates, and tools used in clinical research execution.
- Undergraduate degree (or equivalent) in a biomedical, scientific, or statistical discipline.
- Good Clinical Practice Certification.
Essential
- Minimum two years’ experience supporting clinical research activities.
- Experience contributing to:
- Clinical study execution
- Data collection and analysis
- Study documentation and reporting
- Working knowledge of clinical research methodologies.
- Experience working within cross-functional teams.
- Working knowledge of:
- FDA, EU MDR and UKCA clinical evidence requirements
- ISO 14155, GDPR, and research governance frameworks
- Experience supporting evaluations of medical devices and/or Software as a Medical Device.
- Exposure to AI-based medical device evaluation.
- Experience supporting multi-region or global clinical studies.
- Exposure to endoscopy or related procedural specialities.
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Vacancy posted 11 days ago
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