Clinical Trial Manager

Был больше месяца назад

По договорённости

Соискатель скрыл дату рождения, не состоит в браке, детей нет

Москва

Павелецкая

Занятость

полная занятость

Гражданство

Россия

Контакты

Телефон

Почта

Будут доступны после открытия

Профессиональные навыки

Английский язык
Работа в команде
Деловая переписка
MS Excel
MS Office
Управление проектами
Ответственность
MS Outlook
Внимание к деталям
Контроль качества
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Фото, имя и контакты доступны только авторизованным пользователям

Опыт работы 24 года и 9 месяцев

- Апрель 2014 – работает сейчас
- 11 лет и 8 месяцев
Clinical Trial Manager
Syneos Health (formerly Synteract), Москва
Clinical trials
Обязанности и достижения:
- Oversight of the clinical trial activities globally. - Primary contact for CRA, CTA and regional CTM. - Management of CRA team (15 countries, 14 CRAs in the last study). - Training of CRA team. - Organization of CRA calls. - Preparation or revision of project related documents including: monitoring plan, study reference plan, training materials, budgets and proposals, change orders, protocol, informed consent and other subject forms, case report form, statistical analysis plan, data management plan, and clinical study report. - Participation in audits, overseeing follow-up activities and ensuring timely implementation and completion of corrective action plans in close cooperation with QA. - Management of study-specific clinical operations resources in the EU. - Control of clinical part of study budget usage. - Collaboration with vendors. - Management of supplies for clinical studies. - Provision of EU updates and reports. - Final data cleaning. - Review of TMF documents for compliance with GDP. - Preparation of site contract amendments. - Financial reconciliation of site payments.
- Декабрь 2011 – март 2014
- 2 года и 4 месяца
Senior Clinical Research Associate
Synteract, Москва
Clinical trials
Обязанности и достижения:
- Selection of sites. - Monitoring of sites. - Feasibility. - Preparation of submission packages. - Maintenance of Investigator Site Files. - Translation of documents. - Lead CRA activities (local coordination of a study, MV report review).
- Сентябрь 2010 – ноябрь 2011
- 1 год и 3 месяца
Clinical Research Associate
Synteract (formerly Harrison Clinical Research GmbH), Москва
Clinical trials
Обязанности и достижения:
- Monitoring of sites. - Feasibility. - Preparation of submission packages. - Translation of documents.
- Июнь 2007 – сентябрь 2010
- 3 года и 4 месяца
Clinical Research Associate
Quintiles, Москва
Clinical trials
Обязанности и достижения:
- Project experience: 6 international projects, II-IV phase. - Monitoring of sites. - Preparation of documents for submission.
- Октябрь 2003 – май 2007
- 3 года и 8 месяцев
Research worker
Institute of nutrition RAMS, Москва
Science
Обязанности и достижения:
- Preparation of thesis. - Writing articles. - Participation in scientific study of nutrition of Russian population. - Work with database of food consumption in Russian population.
- Март 2001 – сентябрь 2003
- 2 года и 7 месяцев
Nurse boy
Mental Health Research Center RAMS, Москва
Psychiatry
Обязанности и достижения:
- Observation of patients and registering their behavior in the log. - Administration of drugs according to prescriptions. - Physical examination of patients.

Образование

- Кандидат наук
- Дневная/Очная
- 2007
Institute of Nutrition of RAMS
Специальность: PhD in Hygiene
- Высшее образование
- Дневная/Очная
- 2003
Moscow Medical Academy
Факультет: Preventive medicine faculty
Специальность: Medical Doctor in Preventive medicine (Sanitation and Hygiene)

Обо мне

Дополнительные сведения:

Therapeutic area experience in clinical trials Gastroenterology: Ulcerative colitis Hematology: Essential thrombocythaemia, Haemophilia A Infectious Disease: Invasive fungal disease, Hepatitis C, Nontuberculous Mycobacterial Lung Infections, Rabies immunisation, Uncomplicated Urinary Tract Infection Ear and labyrinth disorders: Meniere's syndrome Oncology: Breast cancer, Endometrial Carcinoma, Lymphoblastic leukemia, Non-small cell lung cancer, Ovarian cancer Ophthalmology: Cataract, Glaucoma Psychiatry: Schizophrenia Neurology: Epilepsy Systems Experience Microsoft Windows 10, 11 Microsoft 365 (Outlook, Word, Excel, Power Point) Microsoft Teams and SharePoint Adobe Acrobat Pro Web-based systems (EDC, IxRS, CTMS, Lab portal) SPSS for Windows Photoshop Publications 12 scientific publications and thesis in nutritionology.