Experience

MEDICEM

• Czechia
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Clinical Operations Manager

  • Jun 2018 - Present



Freelance, self-employed

• Litomerice, Czech Republic

• freelance SCRA and CTM

  • Sep 2017 - May 2018

  Open for monitoring or project management projects in the Czech Republic or Germany. Experienced in monitoring in the USA, Germany, India, Russia, Slovakia. 7 years of monitoring experiences including feasibility, start-up, site selection, contract negotiation, IEC submission, SIV, SMV, COV, archiving, payments. Studies in all clinical phases except phase I and all therapeutic areas including oncology, pediatry and vaccines. Have worked for small and big CROs as well as for pharma companies and also as freelancer. Capable of monitoring in Czech, Slovak, English, German and Russian. Some project management experiences, including country lead monitor experience, project budget preparation and supervising and mentoring other CRAs. Show less



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• SCRA

  • Jan 2017 - Jul 2017

  Blinded monitoring and site management of 2 phase III studies in oncology (5 sites and 3 sites), phase III study in psychiatrics (5 sites) and phase II study in diabetology (2 sites). All 8 sites were in the Czech Republic). Blinded monitoring and site management of 2 phase III studies in oncology (5 sites and 3 sites), phase III study in psychiatrics (5 sites) and phase II study in diabetology (2 sites). All 8 sites were in the Czech Republic).



Leading Clinical Research

• Praha, Czech Republic

• Clinical Trial Manager

  • Oct 2015 - Dec 2016

  Monitoring (on-site and remote) and site management of 2 international projects (medical device, gynecology, post-registration) - responsible for sites in USA, Germany, Russia, Czech Republic and Slovakia; 4 other projects in wound healing (medical device, post-registration) and thermal burns (phase III studies, one of them petriatric) Monitoring (on-site and remote) and site management of 2 international projects (medical device, gynecology, post-registration) - responsible for sites in USA, Germany, Russia, Czech Republic and Slovakia; 4 other projects in wound healing (medical device, post-registration) and thermal burns (phase III studies, one of them petriatric)



Bayer

• Chemical Manufacturing
• 700 & Above Employee

• SCRA

  • Feb 2014 - Sep 2015

  Country Lead Monitor in 4 studies (diabetic nephropathy, endometriosis, systemic sclerosis and non-Hodgkin lymphoma) Feasibility, site selection, monitoring, database lock, close-out May 2014 - Aug 2014 CRA in 1 study in endometriosis outsourced from KCR Czech Republic and PRA Health Sciences Czech Republic Country Lead Monitor in 4 studies (diabetic nephropathy, endometriosis, systemic sclerosis and non-Hodgkin lymphoma) Feasibility, site selection, monitoring, database lock, close-out May 2014 - Aug 2014 CRA in 1 study in endometriosis outsourced from KCR Czech Republic and PRA Health Sciences Czech Republic



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• CRA II

  • Aug 2013 - Jan 2014

  worked as CRA on flu vaccine study with 260 subjects outsourced from RPS (PRAHS) worked as CRA on flu vaccine study with 260 subjects outsourced from RPS (PRAHS)



ICON plc

• Ireland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• CRA I

  • Nov 2011 - Jul 2013

  Feasibility, start-up (contract negotiation, CDP, PSV), unblinded monitoring (SIV, SMV), blinded monitoring (SIV, SMV, COV). Clinical Research Therapeutic Areas include: Oncology - Non-small-cell Lung Cancer (unblinded SIV, SMV), phase III Urology - Chronic prostatitis/chronic pelvic pain syndrome (Feasibility, start-up, PSV, CDP, CTA, SIV, SMV, COV), phase II Diabetology - Type 2 diabetes mellitus (start-up, PSV, CDP, SIV, SMV, COV), phase III; Diabetologic Nephropathy (Feasibility) Gastroenterology - Ulcerative colitis (PSV) Neurology - Cerebral Palsy (Feasibility) Cardiology - Cardiovascular disease combined with T2M (SIV, SMV), phase III; Hyperlimidaemia (PSV) Show less



N/A

• maternity leave

  • Apr 2007 - Oct 2011



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• CRA EL

  • Mar 2006 - Mar 2007

  Unblinded monitoring (SMV) in Rheumatology - Rheumatoid arthritis, phase III Unblinded monitoring (SMV) in Rheumatology - Rheumatoid arthritis, phase III



Valeo

• France
• Motor Vehicle Parts Manufacturing
• 700 & Above Employee

• Site Environmental Officer

  • Jul 2005 - Dec 2005

  Performed duties defined by environmental law, fulfilling tasks concerning ISO 14001 certificate, communication with the authorities. Prepared a projekt to eliminate the emissions from the assembly line. Performed duties defined by environmental law, fulfilling tasks concerning ISO 14001 certificate, communication with the authorities. Prepared a projekt to eliminate the emissions from the assembly line.



Plant Protection Chemistry NZ

• Rotorua, New Zealand

• Postdoctoral fellow

  • Mar 2004 - Mar 2005

  Managed own research project, performed independent research and planned the following projects. Presented results of research on international conferences. Managed own research project, performed independent research and planned the following projects. Presented results of research on international conferences.



Institut für Zelluläre und Molekulare Botanik

• Bonn, Germany

• scientist, PhD student

  • Aug 2001 - Jan 2004

  Managed own research project, independent research and planning of following projects. During this time I was working on my PhD thesis. Laboratory Teaching, University of Bonn (in German) I was leading 4 weeks long laboratory (“Praktika” ) classes of 3-5 students per session on how to not plan, do and evaluate experiments and how to present the results. Managed own research project, independent research and planning of following projects. During this time I was working on my PhD thesis. Laboratory Teaching, University of Bonn (in German) I was leading 4 weeks long laboratory (“Praktika” ) classes of 3-5 students per session on how to not plan, do and evaluate experiments and how to present the results.



Lehrstuhl für Botanik II – Ökophysiologie und Vegetationsökologie

• Würzburg, Germany

• scientist, PhD student

  • Sep 2000 - Aug 2001

  Managed own research project, independent research and planning of following projects. During this time I was working on my PhD thesis. Laboratory Teaching, University of Bonn (in German) I was leading 4 weeks long laboratory (“Praktika” ) classes of 3-5 students per session on how to not plan, do and evaluate experiments and how to present the results. Managed own research project, independent research and planning of following projects. During this time I was working on my PhD thesis. Laboratory Teaching, University of Bonn (in German) I was leading 4 weeks long laboratory (“Praktika” ) classes of 3-5 students per session on how to not plan, do and evaluate experiments and how to present the results.



Ministry of Environment

• Czechia
• Government Administration
• 100 - 200 Employee

• Referent on international and strategic EIA

  • Sep 1999 - Dec 1999

  Responsible for managing transboundary EIA for the Espoo convention: Was preparing the agreement with the German Ministry of the Environment regarding transboundary EIA and presented a report about the Espoo convention in Czech Republic in Geneve (see above). I was also responsible for agenda concerning Aarhus convention and also agenda concerning strategic EIA (the transport strategy). Responsible for managing transboundary EIA for the Espoo convention: Was preparing the agreement with the German Ministry of the Environment regarding transboundary EIA and presented a report about the Espoo convention in Czech Republic in Geneve (see above). I was also responsible for agenda concerning Aarhus convention and also agenda concerning strategic EIA (the transport strategy).