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Senior Clinical Study Manager

Company: Meet
Location: Anaheim
Posted on: November 19, 2022

Job Description:

A fantastic opportunity is available with a growing biotech firm located in San Mateo. Our client is looking for a Senior Clinical Study Manager with a high level of knowledge of clinical operations and the ability to lead all aspects of assigned clinical trials. The Clinical Study Manager will ensure successful clinical trial planning, execution, and delivery within the specified quality, time, and cost parameters.
Job Description:

  • Ensures that TMF for an assigned clinical trial(s) is created, maintained, monitored, and closed timely
  • Site monitoring reports are accurate and thorough and those metrics are being adhered to
  • Utilizes project management skills to ensure consistency and drive Clinical Operations performance
  • Central Lab and ancillary vendors selection, set-up, conduct, and close-out for the studies
  • Oversees and/or delegates the management and oversight of study vendors (CRO) to ensure clinical trials are getting the necessary resources and attention from vendors, ensures trial deliverables and performance goals met
  • Adheres and contributes to the development and review of Clinical Operations Work Instructions and SOPs
    Qualifications:
    • Bachelor's degree or higher in a scientific or healthcare discipline preferred
    • 3-5 years of experience in clinical research or clinical operations within the biotech, pharmaceutical sector, or CRO industry
    • Documented training and application of FDA Regulations, GCP, and ICH guidelines in clinical trials
    • Experience developing trial plans including site monitoring, pharmacy and lab manuals, risk mitigation strategies, trial budgets, and site selection/feasibility as required
    • Management experience of CROs, Vendors, and Consultants preferred
      Please contact Samantha Vankoll at (628) 336-2756 or email samantha@peoplewithchemistry.com if you would like to know more about this opportunity.
      This will be 100% confidential.Find out more about Meet at www.peoplewithchemistry.com

Keywords: Meet, Anaheim , Senior Clinical Study Manager, Executive , Anaheim, California

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