Clinical Project Manager

Company Name: 
Category: 
Biotechnology
Healthcare
Project Management
Status: 
Full-Time
Post Date:  
5/28/2019
Contact Email: 
Description: 
Clinical Project Manager
PhotoniCare – Champaign, IL
 
PhotoniCare, Inc. (www.photoni.care) is a medical device manufacturer located in Champaign, IL. We believe better decisions in patient care need to be made at the front lines of medicine, prior to specialty care, so we can improve outcomes and save on downstream healthcare costs. As a result, we’ve developed a low-cost handheld imaging platform that uses light to see through tissue. Our first product on this platform is empowering frontline providers to make better decisions about middle ear infections, the leading cause of hearing loss, antibiotic use, and surgeries in children.
 
PhotoniCare has developed the TOMi™ Scope, a handheld imager designed to look and handle like the familiar otoscope. Our TOMi Scope provides unprecedented non-invasive views of the middle ear in real-time using our patented imaging platform technology. Alongside a real-time, high quality surface image, the TOMi Scope provides a view through the eardrum to directly visualize the contents in the middle ear.
 
PhotoniCare’s patented imaging platform technology provides growth opportunities beyond otology (study of the ear). Plans to expand our platform to interrogate diseases in additional tissue sites are also underway.
 
What We Are Looking For
The Clinical Project Manager will oversee one or more clinical studies or trials as part of PhotoniCare’s clinical evidence strategy. Additionally, the Clinical Project Manager will be responsible for contributing to the strategy and long-term planning of the internal clinical program, assembling and managing a team that will work together to execute the clinical plan, and contribute to dissemination of results to all relevant stakeholders. The candidate must be able to:
  • Coordinate and manage performance of clinical sites, including pre-study selection, site initiation, comonitoring, and close out monitoring visits
  • Draft study related plans
  • Resolve logistical, data, site, and audit issues
  • Participates in system building, maintenance, and data scrubbing, i.e. Electronic Data Capture (EDC)
  • Participate in study start-up activities
  • Present progress reports at internal investigator meetings
  • Present and represent the company at relevant conferences
  • Data analysis and manuscript writing and management

Requirements

  • BS in life sciences, engineering or related technical field (or equivalent)
  • 5+ years of clinical research experience (medical device and/or otology applications preferred)
  • Knowledge of clinical monitoring and applicable regulatory requirements
  • Attention to detail and a methodical and systematic approach to work
  • Able to proactively and independently resolve issues
  • Ability to work in a fast-paced environment, managing multiple priorities
  • Strong interpersonal skills and an ability to communicate at all levels
  • A proven ability to organize, prioritize, take initiative and work and follow-up independently
  • Ability to travel - up to 20%
  • Highly organized around priorities, velocity, quality, and meeting deadlines
  • Self-starter, energizing, and results-oriented
  • Strong sense of accountability and ownership
  • An entrepreneurial spirit that is flexible, experimental, and resourceful
What Will Help You In This Role
  • Early stage experience in high growth environment is a plus
  • Knowledge of medical device product management
  • Experience in a regulated clinical environment
  • Experience with Clinicaltrials.gov and other clinical regulations
  • Experience with clinical support software, such as REDCap, Medrio, or similar
Additional Considerations
How To Apply
Please respond with cover letter, resume, and 3 references to hr@photonicareinc.com.