Clinical Project Manager

Interesting opportunity with a growing, commercial stage company that has developed FDA approved systems that significantly improve treatment of atrial fibrillation. Work as a key Clinical Affairs team member in a collaborative, cross functional environment, and manage the execution of Phase II – IV cardiovascular device trials. Monitoring is mostly remote, with modest domestic travel.

Responsibilities:

  • Provide overall clinical site management from qualification and start-up to closeout.
  • Serve as liaison between sponsor, site Investigators, and Study Coordinators regarding protocol questions, queries, and enrollment.
  • Responsible for site communication and instruction on clinical processes.
  • Maintain audit-ready Trial Master File via regulatory document collection, review, and tracking.
  • Conduct on-site/remote Site Initiation Visits, Interim Monitoring Visits and Closeout Visits according to Monitoring Plan and Data Management Plan. Activities include source document verification, electronic/paper CRF review, protocol and regulatory compliance, device accountability, and visit report writing.
  • Complete study and clinical site status reports; provide ongoing status updates to management.
  • Develop clinical trial documents and materials.
  • Ensure that clinical trial is conducted in compliance with study protocol, SOP’s, FDA guidelines, GCP Guidelines, and ISO standards (as applicable).
  • Facilitate clinical site contract and budget process.
  • Collaborate with Regulatory Affairs on FDA and international regulatory submissions.
  • Work closely with clinical project and commercial teams, external vendors (e.g., data management CRO, core lab).
  • Conduct internal audits.
  • Process and track site payments per approved budget.
  • Verify proper device shipment, accountability and disposition.

Required qualifications:

  • BS or greater in biology, health, medical or clinical sciences (e.g., Physiology or Nursing).
  • 5-10 year’s medical device clinical research experience in an operating company or CRO setting.
  • Clinical monitoring experience, including independent monitoring of medical device trials.
  • Previous experience in a Phase II or III clinical trial, with cardiovascular experience preferred.
  • Thorough understanding of Good Clinical Practices, ICH and FDA guidelines for clinical trials.
  • Experience with Electronic Data Capture (EDC) systems.
  • Solid computer skills (Microsoft Word, Outlook, Excel and PowerPoint).
  • Ability to work on multiple projects in fast paced, dynamic environment.
  • Excellent interpersonal, organizational, and critical thinking skills.
  • Strong written, verbal, and presentation skills.
  • Positive, self-motivated, creative, detailed, and solutions-oriented with the ability to work independently as well as collaboratively in a team environment.
  • Travel: currently 10-20%.