Sr. Clinical Project Manager

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

Digital Diagnostics is looking for a Sr. Clinical Project Manager to join our growing team. As the Sr. Clinical Project Manager, you will be responsible to plan, develop, and follow systems and procedures to ensure optimum compliance in accordance with GCP/ICH guidelines and FDA regulations, and to ensure operating quality and efficiency. The Sr. Clinical Project Manager works closely with the organization departments to execute the trial She/he will need to engage and work closely with CROs and Vendors that execute the study operations. Dedicated focus is on study management activities which may include vendor oversight.

What You’ll Bring to the Team 

Required

• Experience authoring core study documents (protocols, clinical plans, ICF, SOPs, etc.)
• Experience leading clinical studies
• Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials
• Ability to work in a fast-paced medical device environment
• Has strong interpersonal and writing skills
• Able to multitasks, prioritizes, and meets deadlines in a timely manner
• Collaborate across teams to meet business objectives and gain alignment
• Led cross-functional team meetings independently to drive decision-making and processes

Preferred

• Experience in therapeutic area in Ophthalmology, Diabetes, and/or Diabetic Retinopathy
• Medical device experience

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, LumineticsCore™ (formerly 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.

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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).

No external agencies at this time, please.