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Senior Clinical Trial Manager

Company: Meet
Location: San Diego
Posted on: November 11, 2019

Job Description:

Company Overview:
Meet is currently working with a company who is seeking a Clinical Trial Manager/Sr Clinical Trial Manager to join the Clinical Development Team. As a member of our team, you'll work closely with internal team members and vendors as well as clinical study sites ensuring that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals and budgets. You'll have responsibility for managing the operational aspects of clinical trials including managing clinical operations personnel.
Job Description:

  • Managing the operational aspects of clinical trials
  • Managing Clinical Operations personnel
  • Managing the study project plan, including timeline, budget and resources
  • Participates in protocol, CRF and strategy development, Clinical Study Report preparation, and NDA submission'
  • Preparing metrics and updates
  • Proactively identifying potential study issues/risks and recommending/implementing solutions

    CRO/vendor activities including:
    • Participating in and facilitating the CRO/vendor selection process for outsourced activities
    • Managing CRO interactions including sponsor oversight of operational functional activities (study management, monitoring, site management, project master files)
    • Working with the CRO to develop and revise scope of service agreements, budgets, plans, and detailed timelines ensuring that performance expectations are met
    • Preparing, reviewing, and approving study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual and CRF Completions Guidelines)
    • Managing clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations
    • Participating in the development, review and implementation of departmental SOPs and processes
    • Recommending and implementing innovative process ideas to positively impact clinical trials management
    • Organizing and managing internal team meetings, investigator meetings and other trial-specific meetings; serving as a liaison and resource for investigational sites
    • Reviewing site study documents (informed consent template and study tools/worksheets), investigator contracts, and site payments
    • Participating in the selection, training and evaluation of study personnel (contract and internal) to insure the efficient operation of the function
    • Serving as a liaison and resource for investigational sites

Keywords: Meet, San Diego , Senior Clinical Trial Manager, Executive , San Diego, California

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