Location – Chicago, IL | Coralville, IA | or Remote-US

Digital Diagnostics is looking for a Clinical Project Manager (CPM) to join our growing team! The Clinical Project Manager position leads and drives the project in the planning, execution, and management of all clinical operational aspects by collaborating with internal and external partners with a focus on agility, learning, and creative thinking to move forward in a fast-paced innovative environment. In addition, the CPM ensures clinical research studies are conducted in accordance with the protocol, GCP / ICH guidelines, FDA regulations, and departmental SOPs.

Essential duties include, but are not limited to:

• Leads and drives the project team in the planning, execution, and management of all operational aspects.
• Develop and/or review clinical study documents including protocols, informed consent forms, and study-related plans and manuals.
• Coordinate Institutional Review Board / Ethical Committee submissions and notifications.
• Develop and maintain effective relationships with clinical study sites.
• Serve as primary Sponsor contact and provide direction for CRO(s), independent contractors, and other third-party vendors.
• Monitor data quality and ensure appropriate quality measures are in place.
• Maintain study documents /trial master file (TMF) and ensure inspection readiness.
• Participate in the preparation, review, updating and training of SOPs.
• Travel as needed to monitor clinical study sites to ensure studies are conducted in accordance with the protocol, GCP/ICH guidelines, applicable FDA regulations and departmental SOPs.
• Track and report on the progress of assigned clinical trials including budget and timelines.
• Participate in the internal testing and ongoing efficacy monitoring of DDx AI devices.

What You’ll Bring to the Team

• Bachelor’s degree in life sciences or related discipline.
• 5+ years of clinical trials management experience, preferably with medical devices.
• Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials.
• Strong time and project management skills.
• Genuine commitment to teamwork in a fast-paced, entrepreneurial environment.
• Strong verbal and written English language communication skills.
• Ability to multitask.

What We Have to Offer

• Supportive and flexible work environment.
• Remote-friendly culture.
• Access to competitive benefits.
• Mission-driven teammates who are working to tackle complex challenges to help improve the accessibility and quality of medical diagnosis.
• Core behaviors that inspire day-to-day interactions.
• Dedication to career growth and development of our team members through mentorship programs and defined growth paths.
• Virtual social and wellness events.

Who We Are

Digital Diagnostics Inc. is a pioneering AI diagnostics company on a mission to transform the quality, accessibility, equity, and affordability of global healthcare. We pursue our mission through the application of technology in the medical diagnosis and treatment process. The company, originally founded by Michael Abramoff, MD, PhD, a neuroscientist, practicing fellowship-trained retina specialist, and computer engineer, is led in partnership with co-founders, John Bertrand, and Seth Rainford. Digital Diagnostics’ first FDA De Novo cleared autonomous AI system, IDx-DR, is already improving patient outcomes by detecting diabetic retinopathy (including macular edema) at the point-of-care.

Digital Diagnostics is paving the way for autonomous AI diagnosis to become a new standard of care, contributing to democratizing healthcare and closing care gaps. The company works closely with patient advocacy groups, federal regulators, and other quality of care and ethics-focused stakeholders to enable adoption of autonomous AI. For more information and the latest news follow: https://digitaldiagnostics.com/

What We Believe

At Digital Diagnostics, we’re doing “AI the right way” by building healthcare solutions that are safe, equitable, and accessible. We’re not only building a platform; we’re also building a community that emulates these values. We believe that inclusion and equity in healthcare start with a community of collaborators that celebrates human differences including race, ethnicity, gender, age, sexual orientation, human need, veteran status, political affiliation, and religion. We value what makes each person unique and create a place for everyone to thrive as we build towards shared goals. We’re committed to continuous learning and are striving to create a principled workplace while continuing to impact the world around us.

This position can be located anywhere in the United States. We are not currently accepting applications for candidates located in countries outside of the U.S. Unfortunately, we are not able to sponsor an immigration case for employment at this time (for example, H-1B or other employment-based immigration cases).