Clinical Project Manager

Posted 3 years ago

We are actively seeking a dynamic professional for a promising opportunity as Clinical Project Manager, will be responsible for working cross-functionally to develop the Clinical Strategy Plans to develop and conduct clinical research initiatives.

Job Description

  • Comprehensive study management for Post-Market clinical initiatives
  • Ensure all research programs are conducted in accordance to approved project plan, compliance to company standard operating procedures.
  • Manage Study Approval process and provide Study Status Reports through monthly meetings with various cross-functional Leadership teams
  • Attending meetings to present data and develop partnerships
  • Quality Assurance support and management level representation during audits and inspections
  • As required to perform other clinical duties as well.

Required Skills

  • Bachelor’s degree in Science, Engineering, or related medical/scientific field
  • 10+ years of medical device clinical research experience
  • Experience in conducting Pre- / Post-Market Clinical strategies to align with business objectives; experience in Class II and III medical devices
  • Experience working with physicians within the Peripheral, Cardiovascular, and Neurovascular therapeutic environment
  • Experience with site and sponsor level FDA BIMO investigation(s)
  • Experience collaborating with Marketing, Sales, Professional and Clinical Education (PACE), Medical Affairs, and Field Clinical to understand and develop Clinical Strategy Plans
  • Experience in data management, safety surveillance, Market Access, and Medical Writing

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