Lona Gonzales

Clinical Team Manager at Akeso, Inc. 康方生物医药有限公司
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Contact Information
us****@****om
(386) 825-5501
Location
Brisbane, Queensland, Australia, AU

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Credentials

  • Board Certified Pharmacist
    Philippine Professional Regulation Commission
    Feb, 2004
    - Nov, 2024
  • Barnett Expert GCP Accreditation Exam
    Barnett International

Experience

    • China
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Clinical Team Manager
      • Apr 2021 - Present

      - Responsible for building and maintaining a compliant in-house clinical monitoring unit, including writing SOPs and clinical management plan templates, and supporting the design of clinical systems. - Responsible for recruiting and overseeing the CRA/CTA team onboarding, training and personal development. - Oversees and manages the CRA/CTA team, monitoring their performance, conducting performance appraisals and supporting performance improvement plans. - Responsible for managing CRA/CTA project assignments, turnover and retention, and conducting oversight visits with CROs. - Involves in site start-up and monitoring, writing and reviewing monitoring reports, approving site payments and participating in clinical trial audits.

    • Ireland
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Senior Clinical Research Associate
      • May 2019 - Apr 2021

    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • Senior Clinical Research Associate
      • Aug 2016 - Apr 2019

    • Senior Clinical Monitoring Lead
      • Nov 2015 - Aug 2016

    • Senior Clinical Research Associate
      • Oct 2014 - Oct 2015

    • Clinical Research Associate
      • Aug 2012 - Sep 2014

    • Clinical Research Associate
      • Jun 2010 - Aug 2012

    • Switzerland
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Oncology Patient Access Programs Coordinator
      • Feb 2008 - May 2010

Education

  • Centro Escolar University
    Bachelor of Science (BS), Pharmacy
    -

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