Lizaveta S.
Clinical Data Manager at Intego Group, LLC- Claim this Profile
Contact Information
us****@****om
(386) 825-5501
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Location
Ukraine, UA
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Credentials
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IBM Clinical Development Designer
IBMMar, 2022- Nov, 2024 -
GoIT English HTML
GoIT - простой путь в ITJan, 2022- Nov, 2024 -
"Essential requirements of MDR 2007/745"
NPTELJun, 2021- Nov, 2024 -
CBER SBIA (Biologics Evaluation and Research Track)
FDAJun, 2021- Nov, 2024 -
CDER SBIA (Drug Evaluation Track)
FDAJun, 2021- Nov, 2024 -
CDRH SBIA (Devices and Radiological Health Track) Regulatory Education for Industry (REdI)
FDAJun, 2021- Nov, 2024 -
ISO Management System Audit Techniques
NPTELDec, 2020- Nov, 2024 -
ISO 14971 Risk Management
UKRMEDCERTOct, 2020- Nov, 2024 -
"Practical aspects of ISO/IEC 17025:2017 ISTL
International school of technical legislation and quality managementJan, 2019- Nov, 2024 -
"ISO 9001:2015 Quality Management System"
NPTEL
Experience
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Intego Group
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United States
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IT Services and IT Consulting
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100 - 200 Employee
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Clinical Data Manager
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Oct 2021 - Present
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Senior specialist of certification and conformity assessment
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Jun 2021 - Oct 2021
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"Ukrainian Center of Medical Certification and Prognostication"
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Kyiv City, Ukraine
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Auditor
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2020 - 2021
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Education
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Ukrainian Military Medical Academy (UVMA)
Master of Pharmacy (Postgraduate continuing education), Pharmacy Administration and Pharmacy Policy and Regulatory Affairs -
National Medical University 'O.O. Bogomolec', Kyiv
Master's degree, Pharmacy -
National Technical University of Ukraine 'Kyiv Polytechnic Institute'
Bachelor's degree, Engineering of Pharmaceutical and Biotechnology equipment
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