Clinical Project Manager

  • 100000 USD - 140000 USD
  • Irvine, United States
  • Permanent

Job Description:

  • Develop and manage clinical project plans to identify and complete clinical trial milestones with accountability for successful completion of all project deliverables for high-profile and complex clinical trials in accordance with GCP, all applicable regulations, and SOPs. Serve as the primary lead of assigned clinical trial(s)
  • With management oversight, provide direction and oversight cross functionally and with CRO (if applicable) to execute projects for multiple clinical studies and initiatives on schedule and within budget
  • Assess the need for clinical trial resources, develop enrollment, and budget forecasts, and set priorities for projects with management
  • With management oversight, manage project status and appropriate communication both internally and externally including key opinion leaders
  • Present trial information at executive and clinical trial meetings (e.g., Investigator and other company meetings)
  • Analyze trial performance to plan and develop corrective actions with management
  • Anticipate and communicate study risks and lead in the implementation of mitigation strategies
  • Participate in the preparation of clinical portions of IDE and PMA submissions


Minimum Requirements

  • Bachelor’s degree with 6 years of previous related experience including medical device, pharmaceutical, biotech and/or CRO industry experience inclusive of study management experience managing complex clinical studies OR
  • Master’s degree or equivalent with 4 years of previous related experience as listed above
  • Ability to travel up to 50%


Kristen Tiftickjian Division Manager

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