Працював в 3 компаніях 18 років 1 місяць
Фармацевтика, Медицина та Охорона здоров'я
Clinical Study Manager
Parexel Ukraine
Фармацевтика
10 років
01.2014 - 01.2024
Study start-up activities management in small size and global studies; Coleadership and co-direction to the project team members; Input to project tools, project plans, Central File Maintenance Plan, Safety Management Plan; Central File quality check, address identified and escalated site issues and drive to closure. Monitor study timelines, patient recruitment, retention and data cleaning to ensure successful outcome of the project Participate in client, investigator and team meetings as appropriate; Working with multiple Clinical Trial Management Systems, Pricing Tools, TIME Management Tools, Financial Forecast Tools used for Financial analysis, Project Tasks management. Quality visits with the newly hired employees. General Practitioner/Consulting Physician, part time State Pharmaceutical Academy KHARKOV STATE MEDICAL UNIVERSITY International Non-Governmental Clinical Research Organization U State Expert Center Inspections and FDA Audit preparation, Responses and corrective actions preparation and review with employees.
General Practitioner/Consulting Physician, part time
Pharmaceutical academy
Медицина та Охорона здоров'я
10 років
01.2012 - 01.2022
Medical consulting, diagnostics and treatment in Cardiology, Endocrinology, Rheumatology, Pulmonology patients, palliative therapy in oncology patients in Medical Care Unit within in-patient's Clinic in Therapy Department, Rheumatology Department in the Kharkov City Clinical Hospital #20
Clinical Research Associate, Functional Leader
International Non-Governmental Clinical Research Organization
Медицина та Охорона здоров'я
8 років
01.2006 - 01.2014
Clinical trials monitoring in accordance with the ICH guidelines, the current monitor guidelines and SOPs including identifying sites, preparing documentation for necessary approvals, initiating sites and observing recruitment, performing monitoring at sites, reporting visits and contacts with site. Co-monitoring visits with the newly hired employees. Audits preparation and responses revision with newly hired employees/Quality Leads.
Ключова інформація
Time management, resource management, cooperation, coordination, multidiscipline management
Навчався в 2 закладах
KHARKOV STATE MEDICAL UNIVERSITY
medicine
Kharkov , 2005
KHARKOV STATE MEDICAL UNIVERSITY
medicine
Kharkov, 2001
Володіє мовами
Англійська
вільно
Іспанська
середній
Російська
рідна
Курси, тренінги, сертифікати
ICH GCP
Clinical trials management, medical research
Dmitry
Dmitry
Medical advisor, Clinical Trial Manager
Київ
повна зайнятість, неповна зайнятість, проектна робота
Оновлено 1 місяць тому