overall responsibility for the clinical studies management for clinical trials in Ukraine.Line Management: CRAs training, CRAs assessment, expense reports approval, co-monitoring visits+ Project Management overall responsibility for the clinical studies management in Ukraine (Phases I - IV)+ Administrative work contracts negotiation, vendors’ assessment, legal presentation of the company, budget control, issues resolution. Interacting with Sponsors and CROs.

Primary point of contact for a CRAs in a group of studies (pediatrics, pulmonology, cardiology) overall responsibility for the clinical studies management, ensuring that clinical studies are effectively conducted and completed within budget and timelines, and enrollment figures are achieved.

Line Management for Czech Republic, Hungary, Poland, Ukraine and Russia, appraisals, co-monitoring visits, trainings and regular reports. QA responsibilities (QA co-monitoring visits conducted every half of the year)Training activities for CROs representatives (CRAs, project assistants etc.) Clinical Site Manager Responsibilities Documents preparation and submitions to Regulatory and Ethicsorganization of biosamples export, IMP import and other activities needed for trials conduction in Russia and Ukraine.All kind of monitoring visits. Contracts negotiation process. Preparation and control of the Initiation visits performing by CRO representatives. Trainings on study procedures. start-up, study conduction and handover in oncology studies. Project Manager in oncology studies (head and neck cancer) start-up activities in the study including site ready preparation and CRA trainings before sites initiation, QA co-monitoring visits during the study.Start-up Manager Phase I study (schizophrenia) all steps of the Phase I study conducted at the first time in Russia.

Clinical Trials monitoring in accordance with the ICH GCP Guidelines, the current monitor guidelines and SOP’s including identifying sites, preparing documentation for necessary approvals, performing qualification visits, initiating sites and observing recruitment, performing monitoring at sites, reporting visits and contacts with site, interacting with investigators to obtain necessary documentation during the study, assuring the presence of all relevant documents on site, collaborating with other departments for reporting safety information, collecting Case Report Forms, following up and solving data queries, reporting the progress of the study on a regular basis and performing site close-out visits. As a Sponsor’s representative I was responsible for the start-up of the new study including submition process, trainings for CRA and Initiation visits preparation.

Clinical trials monitoring in accordance with the ICH GCP Guidelines, the current monitor guidelines and SOP’ s including identifying sites, performing monitoring at sites, reporting visits and contacts with site, assuring the presence of all relevant documents on site, collaborating with other departments for reporting safety information, working with electronic CRF, following up and solving data queries, reporting the progress of the study on a regular basis and performing all types of monitoring visits. Preparation and delivery of presentations at investigators meetings. Preparation for and attendance at in-house and on-site audits. Communication with Sponsor.

legal services for the number of clinics in a timely manner (in the areas of medicine, labor, civil law, arbitrage and business planning).

Start-up activities, preparing the agreements, trainings for employees, arbitrage, issue resolution.