Onboarding to MSD projects

Responsibilities included: • Routine monitoring activities in current projects; • Local Study Leader responsibilities in projects MELTEMI, BORA, SOPHOS, PONENTE (all pulmonology); • SMM Leader in MELTEMI project (15 countries – Argentina, Australia, Bulgaria, Canada, Chile, Czech Republic, France, Germany, Poland, Russia, Spain, UK, USA, Turkey) • Early SMM Lead MESSINA project (12 countries) Achievements included: • Cross-functional projects with different AZ Departments (Commercial, Medical) • Feasibility for 2 projects - COPD and gastroenterology • Development "Patient jorney model" for new gastroenterology project in Russia • 2 external audits without critical/major findings • development local monitoring plan, introduction of centrilized monitoring • Preparation and training CRAs for documents and equipment of the project • Presentation of Russia and the local team at global conferences AZ

Responsibilities included: • Implement the preparation, qualification, initiation, monitoring and closure of clinical trials sites; • Keep and maintain all necessary documentation relating to the research process at the level of centers according to GCP, AZ SOPs and local laws; • Timely update information in IMPACT about sites in trials; • Control supply of necessary equipment, lab kits, non-IP medication etc. at the level of sites; • Train and support research team (query, issue resolution); • Implement and monitor payments to the Investigators and Institutions; • Participated projects as CRA: Phase Therapeutic area expertise Stage of project III Pulmonology – Bronchial Asthma (BORA) Routine Monitoring, DBL, Termination (21 sites) III Pulmonology – Bronchial Asthma (SIROCCO) DBL, Termination (10 sites) IIIb Pulmonology – Bronchial Asthma (MELTEMI) Initiation, Routine Monitoring (3 sites) III Pulmonology – COPD (TELOS) Qualification, Initiation, Routine Monitoring, DBL, Termination (9 sites) III Endocrinology - Diabetes Mellitus Type 2 (D1683C00005) Qualification (3 sites) III Cardiology – Chronic heart failure (D1699C00001) Qualification (3 sites) III Pulmonology – COPD (AERISTO) Qualification, Initiation, Routine Monitoring, DBL, Termination (2 sites) III Pulmonology – Bronchial Asthma (NAVIGATOR) Routine Monitoring (2 sites) III Pulmonology – COPD (GALATHEA) DBL, Termination (3 sites) III Pulmonology – COPD (SOPHOS) Routine Monitoring, DBL, Termination (1 sites) IIIb Cardiology - Peripheral Artery Disease (EUCLID) Routine Monitoring, DBL, Termination (5 sites) Achievements included: • Successful audit completion in project: Phase Therapeutic area expertise Type of audit IIIb Cardiology - Peripheral Artery Disease (EUCLID) Internal, AZ company (all sites) III Pulmonology – COPD (TELOS) Sponsor (Pearl), External Falcon (PI Mikhailov S.) • Became Local Study Leader in project:  Control of deadlines;  Control keeping documents for eTMF on country and sites level, QC;  Communication with Global team and Vendors;  Export of equipment (spirometers, e-Diaries);  TC with local team, preparedness for FDA or EMEA inspections;  Control final payments for Institution and Investigators;  Budget control;  Final Submissions to RA Phase Therapeutic area expertise Stage of project III Pulmonology – Bronchial Asthma (SIROCCO) Termination (42 sites) III Pulmonology – Bronchial Asthma (BORA) Routine Monitoring, DBL, Termination (35 sites) IIIb Pulmonology – Bronchial Asthma (MELTEMI) Routine Monitoring (9 sites) III Pulmonology – COPD (SOPHOS) Routine Monitoring, DBL, Termination (12 sites)

Responsibilities included: • Remote clinical monitoring tasks and occasionally visits (5 during working period with Line Manager and CRA) for designated projects in accordance with relevant SOPs and regulations; • Managing/coordinating/supporting clinical monitoring activities remotely - collecting regulatory documentation, drug/supply management and data collection; • Support Investigators in work with different Sponsor'/CRO systems, queries/issues resolution; • Payment/invoice processing; • Preparing CRA for visits according to Sponsor'/CRO monitoring plan; • Routine contacts with sites by phone/e-mail. Achievements included: • Working with numerous clinical team in large clinical study; • Became Region Study Coordinator (Belarus, Georgia, Russia) in SUMMIT project (GSK); • Successful closure of projects within deadlines: Phase Therapeutic area expertise Stage of project III Endocrinology - Diabetes Mellitus Type 2 (TECOS) Data base lock, Termination (26 sites/465 patients) III Pulmonology – Chronic obstructive pulmonary disease (SUMMIT) End of study, Data base lock, Termination (27 sites/339 patients)

Responsibilities included: • Track, scan, code and send documents to the relevant study Work In Progress area (electronic system for documents storage according to naming convention); • Set up and distribution of Investigator Site Files; • Distribution of study documents to sites and/or local authorities; • Assist with quality checks of submission packages; • Assist with the organization of translations of study document; • Assist and tracking with payment/invoice processing; • Assist local clinical/start-up team • Participated projects: Phase Therapeutic area expertise Stage of project III, III b Rheumatology - Systemic Lupus Erythematosus Data base lock, Termination III b/IV Endocrinology - Diabetes Mellitus Type 2 Routine Monitoring III Dermatology - Severe Plaque Psoriasis Initiation Achievements included: • Became CMA I within 4 months

Skills: • biophysical, radiobiological and biochemical methods for the study of biological objects; • SPECT/CT tomography (U-SPECT II MyLabs device) – processing and image reconstruction ; • work with eukaryotic cancer cell cultures; • research topic: targeted intracellular delivery of anticancer drugs Achievements included: • Diploma (research topic): targeted intracellular delivery of anticancer drugs and radionuclides.

Биологический, Биофизика

AstraZeneca, ICH GCP