Experience

• 

  Gts czech

  Jan 2005 - Apr 2012

  Specialista technické dokumentace

  - documentation of node and link objects (SDH, DWDM, dark fiber etc.) in NRM (Network Resource Management) and other related systems and databases

• 

  Quintiles

  Apr 2012 - Nov 2018

  - administrative support for clinical research associates- managing of Trial Master Files- preparation of Investigator Site Files- EC submissions- preparation of payments

  • SrCRA

    Apr 2016 - Nov 2018

  • Clinical Research Associate

    Dec 2013 - Mar 2016

  • Clinical Trials Assistant - GFR

    Apr 2012 - Nov 2013
• 

  Novartis

  Dec 2018 - now

  - manage a multidisciplinary cross functional Clinical Trial Team (medical writing, statistics, data management, monitoring partner, drug supply, regulatory, safety etc.) - ensure effective planning, regular re-evaluation and implementation of assigned clinical studies to adhere to timelines, budget, quality standards and operational procedures.- collaborate with CSMs/CRAs/vendors to ensure smooth study set up and smooth study conduct, reviewing site performance, protocol deviations, ongoing risk assessment and timely issue resolution in alignment with global standard with local regulation requirement- support compilation of study regulatory documents for submissions to competent authorities and ethics-committees Show less

  • Sr. Clinical Project Manager (Global Trial Manager)

    Apr 2023 - now

  • Clinical Project Manager

    Dec 2018 - now