Clinical Validation Coordinator
At IDx, we believe that automation has the potential to transform the quality, accessibility, and affordability of medical diagnosis. IDx is expanding its team after its first product, IDx-DR, became the first ever autonomous Artificial Intelligence (AI) diagnostic system cleared by the FDA.
IDx operates within the regulated medical device industry and is following a highly structured process that requires extensive documentation and record keeping. The position also offers the ability to participate in setting precedent around how autonomous AI should be tested and implemented into healthcare – in a manner that is safe, effective, and equitable.
IDx employees share in the returns of the commercial success they drive. IDx offers a fair salary and benefits package, augmented with an equity stake in the company. We are a private company with substantial funding and a deep product pipeline. Your work will be instrumental in driving IDx’s long-term value. For more info, visit eyediagnosis.net/careers.
What We Are Looking For:
IDx is looking for a highly driven, detail-oriented individual to coordinate our clinical validation activities. The Clinical Validation Coordinator will be responsible for the clinical validation activities of IDx’s medical device AI’s. This includes the planning and management of clinical trial validation for new medical devices, internal testing and ongoing efficacy monitoring of IDx AI devices, and the validation of improvements to existing medical devices, including new clinical trials or studies where applicable. Specific functions include:
- Develop and/or review clinical trial documents including clinical trial and/or study protocols.
- Develop strategies for assessing model validity in a robust and statistically cogent manner
- Develop, implement and improve frameworks to benchmark and advance the performance of models which are deployed in clinical settings
- Provide support for regulatory submissions (e.g. 510k).
- Contribute to and coordinate the interpretation and publication of research results.
- Serve as contact for operational trial-specific issues and study deliverables.
- Serve as primary IDx contact for all external biostatistician contractors.
- Monitor data quality and ensure appropriate quality measures are in place.
- Manage and track handling of data associated with IDx’s clinical efficacy monitoring activities.
- Masters in Biostatistics / MPH / or similar degree with 1-2 years of experience or BS/BA with 3+ years of experience within clinical research, preferably within the medical device industry
- Knowledge of the clinical development and regulatory processes
- A solid practical understanding of statistical methods as applied to clinical research
- Strong time and project management skills
- Exceptional analytical and organization abilities
- Genuine commitment to teamwork in a fast-paced, entrepreneurial environment
- Desire to own decisions and take responsibility for outcomes
- Strong verbal and written English language communication skills
The rigors and challenges of work at IDx are not for everyone, but the team here has some amazing opportunities to:
- Work with world-renowned doctors who are pushing the limits of machine learning in medicine.
- Build upon and contribute to products that will revolutionize health tech.
- Tackle complex problems and projects that will establish precedent for autonomous AI in medicine
- Push the accessibility and quality of healthcare to new heights to improve the lives of millions of people.
How to Apply
If you’re interested in learning more about working at IDx, check out eyediagnosis.net/careers
And if you’re ready to help our team build the future of healthcare, send us your resume and cover letter at [email protected]