IDx Technologies Inc. Clinical Development Manager in Coralville, Iowa
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. This position will offer the ability to participate in setting precedent for how autonomous AI should be 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 manage our clinical development activities. The Clinical Development Manager will be responsible for clinical study delivery including the planning, management, and reporting of studies in compliance with internal and external quality and regulatory requirements, including Good Clinical Practice (GCP). They will also be responsible for internal testing and ongoing efficacy monitoring of IDx AI devices. Specific functions include:
Develop and/or review clinical study documents including protocols, informed consent forms, and statistical analysis plans
Coordinate Institutional Review Board / Ethical Committee submissions and notifications
Develop and maintain effective relationships with clinical study sites
Serve as primary Sponsor contact for operational study-specific issues and study deliverables
Provide oversight of CRO(s), independent contractors, and other third-party vendors
Track study status against milestones, identify and anticipate potential issues and/or challenges, and develop solutions
Develop and manage clinical study budgets
Monitor data quality and ensure appropriate quality measures are in place
Maintain study documents / trial master file (TMF) and ensure inspection readiness
Develop, review, and implement departmental standard operating procedures and processes as needed
Bachelor?s or Master?s degree in life sciences or related discipline
5+ years clinical trials management experience, preferably with medical devices
Strong, detailed knowledge of clinical development and regulatory processes
Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials
Strong time and project management skills
Exceptional analytical and organization abilities
Genuine commitment to team work 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 opportunitites 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 firstname.lastname@example.org