Your Name
Summary
- Involvement in Clinical Research for 15 years, including the roles of Senior Clinical Research Associate (11 years), Local Regulatory Representative (parallel with another role for 2 years), Project Manager and International Project Manager (4 years) being responsible for clinical, interventional epidemiological (genetic screening) and medical device global studies. Working in medical device pivotal and clinical phase II, III, IV studies – more than 2 years in late phase services - with investigational products of chemical and biologic entities or diagnostics. 2 year experience with CEC and CA of Medical Devices in Hungary. 4 years of Senior Scientific Researcher role in Pharmaceutical R&D being responsible for managing generic product development, obtaining and presenting chemical data for regulatory submissions and setting up quality control/assurance parameters of a pharmaceutical product. 6 years of scientific research with medicinal plants for identification and in vitro production of novel tyrosine kinase inhibiting compounds from tissue cultures resulting in PhD degree in Biology. Country specific experience with global project management of sites in Bosnia, Bulgaria, Croatia, Estonia, Greece, Latvia, Lithuania, Macedonia, Poland, Romania, Russia, Serbia, Slovakia, Slovenia, Turkey and Ukraine.
- Therapeutic Areas: Malignant Neoplasms (non small Cell lung cancer (NSCLC), prostate cancer, breast cancer, colorectal cancer, hematology (B-cell chronic lymphocytic leukemia, Lymphoma (T-Cell NHL), Myelofibrosis), Muskuloskeletal and Connective Tissue Disorders (Joint Inflammation / Infection), end stage renal failure, Endocrinology (Growth Hormone Deficiency (pediatric)), Cardiovascular diseases ( Cortical stroke ( Arrhytmia, Hyperlipidemia, Hypertriglyceridemia, Pulmonary, Arterial Hypertension, CNS disorder (Multiple Sclerosis, Epilepsy, Cortical Stroke, Alzheimer’s Disease, Emphysema / Chronic Obstructive Pulmonary Disease (COPD), Seasonal Allergic rhinitis, Angiooedema, Juvenile rheumatoid arthritis (Pediatric), chronic liver disease (primary biliary cirrhosis), Medical device (CVC catheter lock solution), Radiopharmacon (Scintimun granulocyte), Alfa-1-antitrypsin enzyme deficiency, Atopic dermatitis, Arthritis, Osteoporosis, Joint infection, Venous leg ulcers, Neuropathy
- Professional roles: Senior Clinical Research Associate, Local Regulatory Representative, Project Manager, International Project Manager, Freelance Clinical Trial Specialist, Senior Scientific Researcher, Scientific Research Associate, Biologist, Scientific Translator of Texts on Life Sciences.
Overview
27
27
years of professional experience
Work History
Senior CRA
IQVIA Biotech
01.2021 - Current
Clinical Research Specialist
Omnicro Research LP Budapest
08.2019 - 12.2020
Senior CRA
ICON Clinical Research
Budapest
09.2017 - 07.2019
Freelance
Omnicro Research LP
Budapest
04.2016 - 08.2017
Senior CRA
PRA Health Sciences
Budapest
09.2013 - 03.2016
Senior CRA
Aptiv Solutions
Budapest
08.2011 - 07.2013
Clinical Project Manager
Clinical Investigations Kft
Budapest
06.2007 - 07.2011
Contractor CRA
Clinical Investigations Ltd
London
06.2007 - 11.2008
Senior Scientific Researcher
TEVA Pharmaceutical Co
02.2000 - 02.2004
Scientific Researcher
Eötvös Loránd University, Faculty of Sciences
Budapest
11.1993 - 01.2000
Scientific Researcher
Institute for Medicinal Plant Research
11.1996 - 10.1997
Education
Page 3 of 3 - undefined
2022
PhD - Biology, Scientific English
2000
MSc - Biology
1996
undefined
Dr_Kunvari
1993
MSc, PhD - undefined
Monika
MSc, PhD - Biology
Eötvös Loránd University
Skills
- Clinical Research, translation of medical text, protocol review, protocol synopsis preparation, ICF/ PIS preparation, site training, site management, audit preparation, accompanying audit, start-up, regulatory overview, contract negotiation, contract management, budget management, invoice review, feasibility, vendor management, communication with Sponsors, communication with authorities, communication with Investigators, communication with team members, clinical monitoring, project management, query management, working with CTMS, eTMF, eCRF, IWRS
- Vendors: iMedidata RAVE, Oracle Remote Data Capture, OmniComm and Phase Forward InForm systems, ClinTrak Medpace Systems, WingSpan, Veeva Vault eTMF, Oracle and ICON CTMS, PRA CTMS, APTIV SMS, Icotrial, Bracket, Clinphone, Suvoda, Cenduit, Icoflex, Iconik, Icon Central Laboratory, Quintiles Central Laboratory, Covance Central Laboratory, Medpace Central Laboratory
- Computer skills:
- Microsoft office (Word, Excel, Power Point), Windows 7, Windows 10, MacOS)
Additional Information
- Driving license B: over 15 years of active driving
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
swipe to browse
Quote
If you really look closely, most overnight successes took a long time.
Steve Jobs
Timeline
Senior CRA
IQVIA Biotech
01.2021 - Current
Clinical Research Specialist
Omnicro Research LP Budapest
08.2019 - 12.2020
Senior CRA
ICON Clinical Research
09.2017 - 07.2019
Freelance
Omnicro Research LP
04.2016 - 08.2017
Senior CRA
PRA Health Sciences
09.2013 - 03.2016
Senior CRA
Aptiv Solutions
08.2011 - 07.2013
Clinical Project Manager
Clinical Investigations Kft
06.2007 - 07.2011
Contractor CRA
Clinical Investigations Ltd
06.2007 - 11.2008
Senior Scientific Researcher
TEVA Pharmaceutical Co
02.2000 - 02.2004
Scientific Researcher
Institute for Medicinal Plant Research
11.1996 - 10.1997
Scientific Researcher
Eötvös Loránd University, Faculty of Sciences
11.1993 - 01.2000
Page 3 of 3 - undefined
PhD - Biology, Scientific English
MSc - Biology
undefined
Dr_Kunvari
MSc, PhD - undefined
Monika
MSc, PhD - Biology
Eötvös Loránd University