Site Management Country Head

Была больше месяца назад

По договорённости

44 года (родилась 11 января 1981), cостоит в браке, есть дети

Москва

Занятость

полная занятость

Гражданство

Россия

Контакты

Телефон

Почта

Будут доступны после открытия

Фото, имя и контакты доступны только авторизованным пользователям

Опыт работы 17 лет и 10 месяцев

- Февраль 2024 – работает сейчас
- 1 год и 10 месяцев
Global Resource Manager, clinical trials
Bayer, Москва
- Декабрь 2018 – февраль 2024
- 5 лет и 3 месяца
Country Team Lead (People Manager) clinical trials
Москва
Фармацевтическая компания
- Июль 2020 – июль 2021
- 1 год и 1 месяц
Country Head, Site Managment (Short Term Assigment)
Bayer, Москва
- Май 2018 – декабрь 2018
- 8 месяцев
Manager of Monitoring, Site Managment
Bayer, Москва
- Сентябрь 2015 – май 2018
- 2 года и 9 месяцев
Country Lead Monitor
Байер, Москва
http://Www.bayer.ru
Фармацевтический бизнес
- Июнь 2014 – сентябрь 2015
- 1 год и 4 месяца
Senior CRA
Novartis, Москва
http://Www.novartis.ru
Фармацевтический бизнес
- Март 2012 – июнь 2014
- 2 года и 4 месяца
Local Trial Manager
Novo Nordisk
Обязанности и достижения:
Management and implementation of all aspects of clinical trials from trial set up to end of trial, including drafting protocol, CRF, monitor’s manual and all other trial related documents • Projecting and control inventory requirements • Assess project-staffing needs and identify staffing issues (e.g., determine team resource needs and work with line management to request resources) • Perform country and site feasibility • Collaborate with monitor in site selection and ensure timely trial initiation, recruitment and closure. • Creating local country/BA recruitment plan, including key timelines and monitoring frequency • Create, manage and control of local trial budgets • Negotiate Finance Trial Agreements with Investigators and monitor payments • Ensure that project pre-defined vendors are operational for the country and if applicable, identify local vendors, create and negotiate agreement with these vendors • Provide vendors and external clients with timely project status information and serve as the key operational interface among the Clinical project team • Ensure that the central IEC is provided with current and complete copies of all documents that the IEC requests and a copy of the valid written IEC approval of all related documents is obtained. • Ensure that local RA approval and import/export licenses are obtained. • Ensure that valid Insurance Certificate is in place • Schedule and conduct local Investigator Meeting if applicable. • Monitoring trial progress, instituting monitors/investigator training and taking any preventive/corrective actions as and when necessary • Track tasks performed by CRAs • Liaise with RTM/ITM for all trial related issues and report trial progress timely • Maintain up-to-date knowledge of trial issues • Coach and guide local monitor to achieve targets within an assigned local/CDP trial • Provide input to IO/HQ project team to optimize contribution of clinical trial participation to global development strategies • Providing input to guide team towards achievement of deliverables • Maintain up-to-date knowledge of project issues • Ensuring team achieve targets by sharing experience and knowledge Visit trial sites regularly in accordance with the protocol to perform monitoring activities required Guide site staff/local trial team in preventing protocol deviations (PDs) • Train site staff/local trial team in safety information handling and systems • Meet all local and company requirement with respect to safety reporting
- Июнь 2009 – март 2012
- 2 года и 10 месяцев
Clinical research associate
Novo Nordisk
Обязанности и достижения:
• Ensure trial’s deliverables in Russia by preparation, follow up and timely updates of Trial Tracking Planner, country trial budget, country recruitment and retention strategy • Efficient and accurate site feasibility visits incl. analysis of site logistics, site personnel performance/quality indicators and accountability for patient recruitment strategies • Ensure preparation and submission of local Clinical Trial Application to Health Authorities as soon as possible in order to obtain all necessary regulatory approvals within defined timelines • Negotiate Contracts with clinical trial’s sites and Investigators and track of payments; • Identify potential risks within the appointed trial and proactively take action to prevent or mitigate them • Has good knowledge of trial product and trial protocol and train site staff/local trial team in trial procedures, handling of trial product and documents • Visit trial sites regularly in accordance with the protocol to perform monitoring activities required • Proactive use of EDC for preparation and conduct of site visits as well as source data verification in collaboration with data management • Guide site staff/local trial team in preventing protocol deviations (PDs) • Train site staff/local trial team in safety information handling and systems • Meet all local and company requirement with respect to safety reporting • Collaborate with Data Management in resolving queries • Manage trial product requirements incl. temperature deviations incl. training of site staff • Motivate and build strong relations with site personnel to ensure NN is their preferred provider • Ensure collaboration with and deliveries from vendors locally • Set-up and maintain Trial Master File of appointed trial • Collection and management of essential documents • Participation at Investigators Meetings to ensure relations with sites as well as active presentation • Timeliness in deliveries through process planning and goal setting • Identify potential risks and proactively take action to prevent or mitigate • Knowledge of IW/VRS functions incl. training of site staff • Therapeutic knowledge and general understanding of diseases and treatments • Maintain knowledge of and act in compliance with global and local SOPs, GCP and other regulatory requirements • Support audit and inspections at sites as applicable • Proficient use of NN systems (e.g. IMPACT, CATS) • Perform/review/correct translation of trial related documents
- Февраль 2008 – июнь 2009
- 1 год и 5 месяцев
Junior clinical research accosiate
Novo Nordisk
Обязанности и достижения:
• To ensure high quality of data to satisfy company and HC Authorities by handling of documentation in accordance with Good Documentation Practice; • Alert about any deviations of plans, budgets, quality, timelines, etc; • Always follow local regulations and SOPs related to clinical research; • Has a good knowledge of trial product and trial protocol and train Investigators in the trial procedures; • Visit clinical trial sites regularly and check CRF completion, perform source data verification to ensure liability of information entered into the CRF; • To reveal, register and report all protocol deviations and all adverse events in accordance with SOPs; • Update central data base in IMPACT regularly; • To assure availability and perform accountability of trial product and other trial materials; • To perform or review and correct English-Russian and vise versa translations of various trial related documents; • Participate in departmental meetings and company meetings. • Keep in order documents and correspondence, regularly look through e-mails and response timely. • Follow business ethics principles. • Keep the subordination. Prepare monthly reports on administrative and entertainment expenses (including business card expenses) to the approval of Line Manager • Ensure adequate communication regarding all aspect of the study/ programme to all relevant internal and external stakeholders • Participate in investigator meetings in cooperation with colleagues in the department and other relevant departments in the affiliate to train investigator in objectives and methods of Observational Studies • Follow up and ensure recruitment of subject in accordance with master plan and approved protocol timelines • Contact to CRO/Agencies or IOCDC concerning data management, medical writing and reporting • Follow up and provide study update and feedback to colleagues and other relevant stakeholder, act as interlink between investigators, internal as well as external • Monitor completed CRFs to ensure the integrity, reliability and the quality of the collected data from investigators • Creation and modification all relevant documents (CRF, AE, SAE, pregnancy, synopsis etc) of observational studies presentations for meetings Creation and support Date Base in Excel

Образование

- Высшее образование
- Дневная/Очная
- 2016
Московский финансово-юридический университет
Факультет: MBA
- Кандидат наук
- Дневная/Очная
- 2007
(РНИМУ им. Н.И.Пирогова) Российский национальный исследовательский медицинский университет имени Н. И. Пирогова
Факультет: Медико-Биологический
Специальность: Иммунология и аллергология, Биофизика
- Высшее образование
- Дневная/Очная
- 2004
Российский национальный исследовательский медицинский университет имени Н. И. Пирогова
Факультет: Medical Biological Faculty, Department of medical cybernetics
Специальность: Medical cybernetics

Обо мне

Дополнительные сведения:

Participation in congresses and symposiums 1) Kozir L.A., Bezdetnaya L.N., Gullemin F., Kyagova A.A. Suppression of contact hypersensitivity in mice by photodegradation products of merocyanine 540. Conference devoted to 40-anniversary of Medico – Biological faculty of Russian State Medical University, 5 December, 2003, Moscow, Russia. Book of abstracts, p.212. 2) Kozir L.A., Bezdetnaya L.N., Gullemin F. Photoproducts of merocyanine 540: suppressive effect on T – cell immune response in vivo. All-Russian State Pirogov N.I. Scientific Student Conference with international participation, 18 March, 2004, Moscow, Russia. Vestnik of RSMU, V 34, № 3, 2004, p.165 3) Kozir L.A., Kyagova A.A., Bezdetnaya L.N., Gullemin F., Potapenko A.Ya. Suppression of T-cell immune response in vivo by products of merocyanine 540 photolysis. The third Congress of Biophysitists of Russia, 24 - 29 June, 2004, Voronezh, Russia. Book of abstracts, Voronezh 2004, p. 533 4) L.A. Kozir, A.M. Tikhomirov, A.A. Kyagova and A.Ya. Potapenko. Aggregation of merocyanine 540 in solutions and the rate of its photolysis. 1st international conference “Skin and Environment”, Moscow – St.Petersburg, Russia, 1-6 June, 2005. Book of abstracts, p.67. 5) Potapenko A.Ya., Kozir L.A., Mansurova G.V., Ponomarev G.V., Kyagova A.A. Photooxidation products of photosensitizers are responsible for systemic immunomodulation. 1st International Conference Skin & Environment. Moscow-St. Petersburg, Russia. 1-6 June, 2005. Program and book of Abstracts. Page 38. 6) Kyagova A.A., Kozir L.A., Potapenko A.Ya. Systemic suppression of contact hypersensitivity in mice induced by products of merocyanine 540 photoproducts. 11th Congress of the European Society for Photobiology. ESP 2005. Aix-les-Bains, France. 3-8 September 2005. Programme and Book of Abstracts. PII28. Page 140. 7) Kozir L.A., Tikhomirov A.M., Kyagova A.A. and Potapenko A.Ya. Rate of merocyanine 540 photolysis depends on its aggregation. The fourth congress of photobiologists of Russia, 26-30 September, 2005, Saratov, Russia. Book of abstracts, Saratov, 2005, p.72. 8), A.A., A.A. Tikhomirov, A.A. Kyagova, A.Ya. Potapenko. Effect of aggregation on photolysis of Merocyanine 540, 12th congress of European Society for Photobiology. ESP 2007, Bath, England, 1st-6th September 2007, Programme and Book of Abstracts. OC225, P.81-82. 9) A.A. Kyagova, L.A. Kozir, G.V. Mansurova, Z.I. Moshnina, G.V. Ponomarev, A.Ya. Potapenko, Products of photosensitizer photooxidation are responsible for systemic immunosuppression, 12th congress of European Society for Photobiology. ESP 2007, Bath, England, 1st-6th September 2007, Programme and Book of Abstracts. OC225, P.81-82. 10) A. Kyagova, L. Kozir, G. Mansurova, I. Moshnina, V. Ponomarev, A. Potapenko, Immunosuppressive effect of psoralen photochemotherapy and photodynamic therapy may be realized through production of photosensitizer photooxidation products, Journal of Investigative Dermatology, 2007, V. 127, abs. 248 (oral 055), S.42. Papers 1) L.A. Kozir, A.M. Tikhomirov, A.A. Kyagova and A.Ya. Potapenko. The effect of merocyanine 540 aggregation in solitions on the rate of its photolysis. Vestn. Russ.State Med. Univ. No.7 (46), 2005, Moscow, p.47-52 2) A.M. Tikhomirov, L.A. Kozir, A.A. Kyagova, A. Ya. Potapenko. Aggregation and photobleaching of Merocyanine 540 studied by the method of resonance light scattering. Russian Journal of Physical Chemistry A, Russia, Moscow, 2007, V. 81, No. 8, p. 1-7. Snowboarding, roller-blading Defence of the thesis in immunology/allergology and biophysics