Project manager

Conance, sponsor based MSD

Clinical Operation Manager

С 01.10.2019 по 01.03.2024 (4 года 5 месяцев)

Start-up activities.

Conance, sponsor based MSD

Clinical Operation Manager

С 01.10.2019 по 01.03.2024 (4 года 5 месяцев)

Start-up activities.

Новартис Фарма

CRA III, LL CRA

С 01.03.2019 по 01.10.2019 (7 месяцев)

Central point of communication between Novartis and the Investigator for all clinical trial related activities to assure trials are conducted on time and budget, while fully GCP, ICH and Novartis SOP compliant. Leads internal Novartis teams to coordinate on the local CPO and/or the global level for a clinical trial, when assigned. 1. Nominate new sites for clinical trials; analyze capability and make recommendation for trial inclusion. 2. Assume ambassadorial role to facilitate communication between sites and Novartis line functions and increase value proposition to investigators. 3. Facilitate preparation and collection of site level documents; resolve problems as required. 4. Execute site initiation and training. 5. Implement total site management including monitoring visits, regulatory assessment, drug supply management and resolution of site problems to ensure compliance. 6. Track trial execution milestones; identify problems; resolve issues and escalate as appropriate. 7. Manage recruitment and execute contingency plans, as needed. 8. Complete preparation/generation of study monitoring reports. 9. Manage data at the site; resolve technical and content issues to achieve aggressive database lock targets. 10. Implement site closeout activities. 11. Act as local and/or global CRA lead and author global monitoring plan. 12. Act as a mentor to new associates for purposes of field training, as assigned. 13. Participate in multi-disciplinary teams within CPO and globally to evaluate and implement process improvement. 14. Delivery of patient recruitment and high quality data according to agreed timelines and budget, ensuring adherence to international and local regulations. 15. Feedback of external (investigators) and internal (TA/ BU) customers.

Syneos Health company, Strategic Resources, Novartis sponsor based

Sr. CRA

С 01.11.2018 по 01.03.2019 (4 месяца)

1. Perform site either on-site or remote visits and monitoring activities in accordance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements , and complete appropriate documentation (confirmation, follow-up letters, trip reports and /or communication logs) as required. 2. Assess and ensure overall integrity of study and adherence to guidelines, protocols, and regulations. Evaluate overall performance of site and site staff. 3. Ensure compliance and understanding of study requirements by site contacts. 4. Apply judgment and knowledge to independently resolve site issues. 5. Interpret data to identify protocol deviations or major risks to data integrity. 6. Provide recommendations regarding site-specific actions and use judgment and expertise to assess ability of site staff. 7. Understand project scope, budgets, and timelines and be able to provide input and manage project objectives to meet timelines. 8. Act as a liaison between the company and study site personnel and be able to respond to site concerns and questions. 9. May interact with representatives of Client affiliates both within and outside clinical

inVentivHealth Clinical LLC - Syneos Health company, Strategic Resources, Novartis sponsor based

CRA II

С 01.04.2017 по 01.10.2018 (1 год 6 месяцев)

1. Perform site either on-site or remote visits and monitoring activities in accordance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements , and complete appropriate documentation (confirmation, follow-up letters, trip reports and /or communication logs) as required. 2. Assess and ensure overall integrity of study and adherence to guidelines, protocols, and regulations. 3. Evaluate overall performance of site and site staff. 4. Ensure compliance and understanding of study requirements by site contacts. 5. Apply judgment and knowledge to independently resolve site issues. 6. Interpret data to identify protocol deviations or major risks to data integrity. 7. Provide recommendations regarding site-specific actions and use judgment and expertise to assess ability of site staff. 8. Understand project scope, budgets, and timelines and be able to provide input and manage project objectives to meet timelines. 9. Act as a liaison between the company and study site personnel and be able to respond to site concerns and questions. 10. May interact with representatives of Client affiliates both within and outside clinical

inVentivHealth Clinical LLC, Strategic Resources, Novartis sponsor based

CRA I

С 01.08.2015 по 01.04.2017 (1 год 8 месяцев)

1. Perform site either on-site or remote visits and monitoring activities in accordance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements , and complete appropriate documentation (confirmation, follow-up letters, trip reports and /or communication logs) as required 2. Evaluate overall performance of site and site staff. 3. Ensure compliance and understanding of study requirements by site contacts 4. Ensure adequate enrolment. 5. Apply knowledge to resolve basic site issues. 6. Identify and escalate more complex issues. 7.Interpret data to identify protocol deviations or major risks data integrity.

RusBiont

CRA

С 01.01.2015 по 01.08.2015 (7 месяцев)

• Performs Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule. • Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols. • Collects and reviews regulatory documents as required. • Prepares site visit reports and telephone contact reports. • Resolves site issues, including site recruitment challenges, and determines status for IP shipment. • Informs team members of completion of regulatory and contractual documents for individual sites. • Attends Investigator Meetings (IM) and study specific training meetings. • Participates in feasibility and site identification activities. Assist the Project Team with the day-to-day management of clinical studies as required, including attendance at team meetings.

RusBiont

CTA

С 01.09.2014 по 01.08.2015 (11 месяцев)

• Participation in the formation of the Register (oncology: chronic lymphocytic leukemia, Hodgkin's lymphoma, multiple myeloma): • work with primary documentation of medical centers in order to obtain information on the course of the disease, methods and treatments and the results of therapy, • making the information received in the electronic database of the Register, • writing reports in the prescribed form after the visits. • Participation in internal audit documentation screening program HER2 status.

Университет

Санкт-Петербургская государственная химико-фармацевтическая академия

Университет

СПбЭТК им. Д.И.Менделева

Университет

Методика организации и проведения клинических исследований (GCP)

Родной язык

Русский

Иностранные языки

Английский

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Дополнительная информация

THERAPEUTIC EXPERIENCES in clinical trials Gynecology - Endometrial hyperplasia, cervical hyperplasia. Hematology - Iron overload due to blood transfusion - Iron overload due to blood transfusion in pediatric patients - Multiple Myeloma - Aplastic Anemia - Hereditary Hemochromatosis - Transfusional Hemosiderosis - Immune trombocytopenia - Acute Grafts vs. Host disease - Chronic Grafts vs. Host disease Oncology - mTOR inhibition in breast cancer - mTOR inhibition combo Exemestane, 2nd/3rd line, ER/ breast cancer - hormone receptor-positive HER2-negative locally advanced or metastatic breast cancer which progressed on or after aromatase inhibitor treatment. Endocrinology -Cushing syndrome Tuberous sclerosis