Юлія

Julia Chebotareva
MD, PhD Cardiology
I am M.D, PhD, with 17+ years of industry experience in phase 1-3 clinical trials, worked as CRA,
SrCRA, PM, Medical Monitor and Medical Committee Manager in 50+ global studies in oncology,
pulmonology, rheumatology, cardiology, neurology, gastroenterology, vascular surgery, infectious
diseases, neurology, ophthalmology, pediatric diseases, immunology, congenital diseases,
dermatology and hematology.
In 2023-2024 I also worked for Ukrainian pharmaceutical company as Head of Overseas
Registration Department responsible for medicines registration abroad.

Contact Experience
Phone
2023 - 2024
[открыть контакты](см. выше в блоке «контактная информация»)
Lekhim JSC, Kyiv, Ukraine
Email Head of Overseas Registration Department
[открыть контакты](см. выше в блоке «контактная информация») registartion of Lekhim JSC medicinal products overseas

Address 2019 - 2020
92, Velyka Vasylkivska str., Syneos Health, Kyiv, Ukraine
Kyiv, Ukraine
Medical Committee Manager
management of medical committees (Data Safety Monitoring Board (DSMB), Safety
Education Review Committee (SRC), Endpoint Adjudication Committee (EAC)) including members
identification and selection, contracting, committees' meetings preparation and
attendance in person and on-line, meeting materials preparation and presentation during
2006 meetings, meeting minutes writing and distribution, committee members' remuneration
PhD in cardiology set-up and follow-up.
National Medical University n.a. O.O 2013 - 2019
Bohomolets
PSI-CRO, Kyiv Ukraine
1998
MD Medical Monitor
National Medical University n.a. O.O
consulting project teams and clients on medical matters; development and review of
Bohomolets
medical monitoring and safety reporting procedures; medical review of essential study
documents; review of clinical rationales; audit participation; development of study-
Expertise specific safety management and medical monitoring plans; SAE/AE reporting;
participation in feasibility research; delivering therapeutic area training within the area of
expertise; DMC/DSMB management, Adjudication committee management;
Medical Monitoring communication with customers, sponsors, investigators and key opinion leaders

Medical Committes Management 2003-2013

Project Manaagement PSI-CRO, Kyiv, Ukraine

Medical Review of Clinical Database CRA, SrCRA, PM
management of international trials; project planning; project scope and budget
Pharmacovigilance monitoring; communication with project stakeholders; progress review and reporting;
development of essential documents; resource management and team building; training
Clinical Operations and mentoring of project teams; ensuring compliance with GCP, national regulations,
protocol and quality systems documents; site selection; site initiation; site close-out; site
Medicinal products
routine monitoring; CRF review and source data verification; sites and vendors
registration
communication; regulatory authorities communication; site management; visit reporting
and reports review

Language 1998-2003
Institute of Gerontology AMS of Ukraine
English
Treating Physician, Cardiologist
Ukrainian
Major achievements

Medical monitoring of 19 international studies up to 1200 patients/study with indications of NSCLC,
CABP, cIAI, cUTI, breast cancer, ABSSSI, Crohn’s disease, Multiple Myeloma, bone and joint
infections, cSAB, Multiple Sclerosis.
Medical monitoring in international studies resulted in FDA/EMEA approval of investigated
compounds.
Management of medical committees in 16 phase 1-3 international studies in oncology,
ophthalmology, pediatric diseases, cardiology, immunology, congenital diseases,
dermatology, hematology, infectious diseases.
Set-up, initiation and execution of global clinical trials in different therapeutic areas in Eastern
Europe and Russia. Effective management of 20+ team members.
Successful registration of more than 20 Lekhim JSC medicinal products overseas