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Our small medical device client is adding a Clinical Study Project Manager to the team! The position will report to the Sr. Director of Clinical and will serve a key role in the Clinical Operations department and the company.  The primary responsibility of this position is to provide clinical research expertise to support both internal teams and external customers on the science. Candidates will have the opportunity to thrive in a dynamic, entrepreneurial, and highly collaborative environment contributing to all aspects of Medical Device clinical research projects.

 

Your role with the company:

Clinical Study Management:
  • Lead the internal and external study teams in the successful execution of assigned pre and post-market clinical study(ies)
  • Meet timelines and deliverables while ensuring compliance with GCP, relevant SOP’s and regulatory requirements
  • Develop and execute detailed project plans including site, vendor, and budget management
  • Plan and lead investigator and study meetings as needed
  • Author, review, and approve study protocols and supporting documents including site contracts
  • Drive study start up, patient recruitment, clinical monitoring, and study closeout
  • Plan and coordinate project/protocol specific and therapeutic area training as needed
  • Travel to sites and/or vendors to assess project progress and compliance
  • Ensure study risks are identified, managed, and mitigation strategies are implemented

Clinical Development:

  • Manage and support continued development of an internal clinical data registry
  • Conduct clinical data analysis and ongoing data reviews
  • Develop protocols in collaboration with internal and external therapeutic experts including clinical and health economics endpoints
  • Support and manage Investigator Sponsored Studies as needed
  • Participate in collaborative development of study and publication strategy
  • Support writing and review of regulatory and publication submissions

Other Duties:

  • Serve as clinical operations resource for cross-functional teams including R&D, marketing and medical education
  • Participate in Clinical Operations initiatives, including the development and review of Quality Documents
  • Participate in professional organizations and meetings to maintain expertise and support the company mission
  • Provide support for Patient Assistance Program as requested

Desired Profile:

  • Bachelors degree required; preferable in Life Sciences or Nursing
  • 5+ years of relevant Clinical Research experience
  • Medical Device or Pharmaceutical experience
  • Working knowledge and experience with statistical concepts and principles
  • Familiarity with principles of clinical research design
  • Ability to complete tasks to deadlines and resolve/elevate problems in a timely manner with limited direction
  • Ability to establish and foster effective relationships with investigators, vendors, and internal colleagues that support and advance trial team goals and objectives
  • Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
  • Up to 20% travel

Preferred Skills:

  • Experience with safety surveillance
  • Relevant therapeutic experience preferred
  • Experience running a trial from start to finish

 

 

 

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