Uluk Suharsi Putra

Clinical BA/BE Manager at Pharma Metric Labs
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Contact Information
us****@****om
(386) 825-5501
Location
Jakarta, Jakarta, Indonesia, ID
Languages
  • English -

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Experience

    • Indonesia
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Clinical BA/BE Manager
      • Jan 2022 - Present

    • Clinical Bioavailability/Bioequivalence Assistant Manager
      • Jan 2020 - Dec 2021

      - Coordinates the clinical BABE team to provide and recruit healthy subjects for BA-BE study- Organize, conduct, and ensure the BA-BE study which corresponds with the Good Clinical Practice- Clinical study management- Clinical study budgeting- The clinical study protocol and clinical study report review and approval

    • Clinical BABE Supervisor
      • Feb 2019 - Jan 2020

    • Study Coordination Leader
      • Jan 2017 - Jan 2019

      - Coordinates and ensuring the implementation of GCP by every study personnels on every bio equivalence study conducted.- Ensuring the SOP implementation.- Other Study Coordinator responsibilities.

    • Study Coordinator BA/BE Division
      • Sep 2011 - Dec 2016

      - Study protocol development - BE study subjects recruitment- BE study plan and organization- Ensure the implementation of GCP on every study conducted - Documentation and archiving- SOPs writing- AE and SAE reporting- Budgeting and financial

    • Bio Analysis Staff
      • Jan 2008 - Jul 2011

      Develop the Bioanalytical methods used for bioequivalence study analysis Develop the Bioanalytical methods used for bioequivalence study analysis

Education

  • Universitas Diponegoro
    Bachelor of Science (BS), Biochemistry
    2002 - 2007

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