Gaiva Leoniene

Associate Director, TMF Management at Advanced Clinical
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Contact Information
us****@****om
(386) 825-5501
Location
Phoenix, Arizona, United States, US
Languages
  • English -
  • Lithuanian -
  • Russian -

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Experience

    • United States
    • Biotechnology Research
    • 700 & Above Employee
    • Associate Director, TMF Management
      • Apr 2023 - Present

    • Regulatory Start Up/ Document Management Associate
      • Jul 2015 - Present

    • TMF Manager
      • 2017 - Apr 2023

    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Clinical Study Associate
      • Feb 2015 - Jul 2015

    • Clinical Studies Specialist/ Clinical Documentation Specialist
      • Apr 2014 - Feb 2015

    • Japan
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Regulatory /Compliance
      • 2013 - Apr 2014

    • United States
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Clinical Data Management and Documentation Specialist
      • Sep 2010 - Aug 2012

      As a Clinical Data Manager and a Documentation Specialist, primarily duties include to be part of a clinical research team and to be responsible for data entry and management activities across multiple trials in accordance with FDA regulations and GCP guidelines for Phase I and IV trials. This position’s activities include assisting in data entry, query processing, site management, data reporting and other data management activities in support of clinical trial projects. As a Clinical Data Manager and a Documentation Specialist, primarily duties include to be part of a clinical research team and to be responsible for data entry and management activities across multiple trials in accordance with FDA regulations and GCP guidelines for Phase I and IV trials. This position’s activities include assisting in data entry, query processing, site management, data reporting and other data management activities in support of clinical trial projects.

Education

  • Kaunas University of Technology
    Master's degree, Engineering
    1986 - 1992

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