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Nadezhda Nikolova

Nadezhda Nikolova

Draftswoman

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location of Nadezhda NikolovaBulgaria

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  • Timeline

  • About me

    Project Lead, Infectious, Respiratory and Critical Care Diseases, Project Delivery at PPD, part of Thermo Fisher Scientific

  • Education

    • Medical University Sofia, Medical college "Yordanka Filaretova"

      2010 - 2013
      Bachelor of Pharmacy (BPharm) Pharmacy

    • Shumen university "Episkop Konstantin Preslavski"

      2004 - 2009
      M.A. Linguistics and Translation (German)

    • Shumen university "Episkop Konstantin Preslavski"

      2004 - 2007
      M.A. Linguistics and Translation (Russian)

    • Shumen university "Episkop Konstantin Preslavski"

      2001 - 2004
      B.A. Russian studies

    • Foreign Language High School "Nikola Vaptsarov"

      1996 - 2001
      German and English

    • Bologna Business School

      2023 - 2024
      Master of Business Administration, Executive Master Business Administration

  • Experience

    • Shumenski cadastre Ltd.

      Apr 2004 - Jul 2004
      Draftswoman

    • Algara Ltd.

      Jul 2004 - Jun 2007
      Draftswoman

    • Pavel and sons Ltd.

      Jul 2007 - Jan 2008
      Technical Assistant Investment Projects

    • Toplina Ltd.

      Feb 2008 - Sept 2008
      Draftswoman

    • PPD

      Oct 2008 - now

      Functional role, responsible for the team in Bulgaria Review of final and independent quality control of essential documents required to start and maintain a clinical trial. Doing reviews in global scale, but mainly assigned as primary reviewer for:EMEA: Germany, Switzerland, Austria, Russia, Belarus, Armenia, Georgia;APAC: China, Taiwan, South Korea and Japan.Other names for this process: I(M)P Authorization, I(M)P Shipment, etc. Review of final and independent quality control of essential documents required to start and maintain a clinical trial.Responsible for Bulgaria, Croatia, Serbia and Romania.Other names for this process: IP Authorization, I(M)P Shipment, etc.

      • Project Lead, Infectious, Respiratory and Critical Care Diseases, Project Delivery

        May 2022 - now

      • Associate Project Lead, Infectious and Respiratory Diseases, Project Delivery

        Jun 2021 - Apr 2022

      • Sr. RSM-C II, Centralized Monitoring, Clinical Operations

        Apr 2021 - Jun 2021

      • Sr.RSM-C I, CCM, Clinical Development

        Apr 2019 - Mar 2021

      • RSM-C II, RSMM, Clinical Development

        Apr 2016 - Mar 2019

      • RCR Lead

        Nov 2015 - Jul 2016

      • RCR Reviewer (Central)

        Jul 2015 - Jul 2016

      • RSM-C I, RSMM, Clinical Development

        Dec 2014 - Mar 2016

      • GIS Analyst, Global Investigator Services

        May 2013 - Nov 2014

      • RCR Reviewer (Local)

        Jul 2012 - Jun 2013

      • Country Approval Specialist

        Apr 2013 - May 2013

      • Clinical Submission Specialist

        Dec 2011 - Mar 2013

      • SSUPA, Seniour PA / Contract Specialist

        Oct 2011 - Dec 2011

      • SSUPA, PA II / Contract Specialist

        Oct 2010 - Oct 2011

      • SSUPA, PA I / Contract Specialist

        Apr 2010 - Oct 2010

      • PA I

        Apr 2009 - Apr 2010

      • CPA

        Oct 2008 - Apr 2009

  • Licenses & Certifications

    • InvestPro: Professional Academy in Investment and Personal Finance

      InvestPRO
      Oct 2023

    • InvestPro: Professional Academy in Investment and Personal Finance

      InvestPRO
      Nov 2022

    • InvestPro: Professional Academy in Investment and Personal Finance

      InvestPRO
      Jul 2021

    • Drug Discovery, Development & Commercialization

      Coursera
      Aug 2013
      View certificate certificate