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ЗарегистрироватьсяЖенщина, 44 года, родилась 6 апреля 1982
Санкт-Петербург, готова к переезду (Москва), готова к командировкам
Clinical Research Manager, Clinical Operations Manager, Clinical Project Manager
230 000 ₽ на руки
Специализации:
- Менеджер по продажам, менеджер по работе с клиентами
Тип занятости: полная занятость, проектная работа/разовое задание
Опыт работы 22 года
Апрель 2013 — по настоящее время
13 лет 2 месяца
Медицина, фармацевтика, аптеки... Показать еще
Clinical Operations Manager
Drive 6 phase II/III clinical studies across Russia and 1 study across Russia and Ukraine from start-up to long-term follow-up. Liaise with 23 local/international vendors (e.g. insurance/customs, IP/supplies, data entry, clinical trial management systems). Oversee a total of direct 19 reports.
Clinical Study Expansion/Set-Up
• Achieved a 4-fold increase in subject enrollment in 14 months to 75 subjects from 19 in secondary osteoporosis study, despite 5 subsequent increases of country subject enrollment commitment
o Secured >30% of country enrollment & 6 top-enrollers when selected 14 new investigative sites for 2 psoriatic arthritis & 1 pediatric hematology study
• Initiated 30+ investigative sites, led enrollment of 250+ subjects & oversaw training of 15 clinical research associates
o Performed 28 in-person site co-monitoring visits, 400+ report reviews and 50+ sites feasibility assessments, maintained 100% report review compliance rate.
• Increased site management oversight to 19 sites/117 subjects from initial identification, initiation and set-up of 14 sites/84 subjects for 2 psoriatic arthritic studies.
o Voluntarily added management oversight of 5 sites/33 subjects after cancellation of site participation in Germany/U.S. in 2 psoriatic arthritic studies
o Voluntarily committed to 35% increase of country subject enrollment commitment in pediatric immune thrombocytopenia study
• Prepared 4 initial clinical trial applications approved by regulatory authorities and ethics committees across Russia and Ukraine
• Became 1st of 18 participating countries to obtain approval (75 days) for pediatric immune thrombocytopenia study
Clinical Study Management
• Achieved at least 90% research subject retention rate across all studies
• Increased to 120% from 60% country subject enrollment rate in prostate cancer study,
o Met at least 100% of country enrollment target in all studies
o Spiked to 80% from 14% timely completion rate of case report forms in prostate cancer study
• Prepared 50+ approved clinical trial submissions/notifications to regulatory agencies & institution review boards (IRBs)
• Maintained 100% compliance with project milestones for 2 psoriatic arthritis & 1 pediatric hematology study across: feasibility, regulatory submission, site evaluation, contracting to 1st subject enrollment
o Improved to >90% overall data entry and query resolution rate compliance through spearheading institution of data entry improvement plans at underperforming investigative sites
• Generated 63 country/29 site-specific versions of informed consent forms for 5 studies
• Obtained 20+ investigational product import licenses & biological samples export licenses for 5 studies
Март 2010 — Апрель 2013
3 года 2 месяца
Abbott Laboratories & AbbVie
Медицина, фармацевтика, аптеки... Показать еще
Senior Clinical Research Associate
Drove 5 clinical studies in: liver cancer, breast cancer, Alzheimer’s, schizophrenia, pediatric psoriasis across 15 investigative sites and 120 enrolled subjects. Performed site/country feasibility in all studies with 75 sites approached. Prepared submissions to institution review boards (IRBs). Worked with 16 local/international vendors. Developed/revised country SOP and WI on Regulatory/Ethics Submission and subject’s referral process.
Clinical Research Management/SME
Served as both CRA and study lead in 3 studies (psoriasis, breast cancer, Alzheimer’s); supervised Quintiles (CRO) in breast cancer study
Grew by 40% subject recruitment rate for 170 Alzheimer’s study subjects through increase of potential subject referrals from city clinics/hospitals through initiation of patient referral program
Negotiated ~80% of sites in 2 studies to base budget, freeing up funds for investment in other trials
Март 2007 — Март 2010
3 года 1 месяц
ClinStar Europe LLC, Branch Office
Медицина, фармацевтика, аптеки... Показать еще
Clinical Research Associate
Performed monitoring and site management, IRB/EC submissions and coordination of 5 clinical trial studies
Август 2006 — Март 2007
8 месяцев
ClinStar Europe LLC, Branch Office
Медицина, фармацевтика, аптеки... Показать еще
Clinical Trial Assistant
Administrative support in 4 clinical studies.
Октябрь 2004 — Октябрь 2005
1 год 1 месяц
International Clinic & Hospital MEDEM
Медицина, фармацевтика, аптеки... Показать еще
Front Office Assistant & Cashier
Reception of patients, bill settlement, coordination of patient appointments.
Октябрь 2002 — Октябрь 2003
1 год 1 месяц
Санкт-Петербург, www.bspb.ru
Финансовый сектор... Показать еще
Executive Personal Assistant
Administrative support to Director General
Навыки
Уровни владения навыками
Высшее образование (Бакалавр)
2012
Высшее образование (Бакалавр)
Registsred Nursing, Registered Nurse
2006
Высшее образование (Бакалавр)
Orchestral, Musical Art
Знание языков
Повышение квалификации, курсы
2016
Project Management Course
CBSD Thunderbird Russia
2015
Personal Effectiveness Course 'Influence'
CBSD Thunderbird Russia
Тесты, экзамены
2004
Certificate of Procifiency in English (CPE)
Cambridge English Language Assessment, English
2004
Business English Certficate Higher (BEC Higher)
Cambridge English Language Assessment, Business English
Гражданство, время в пути до работы
Гражданство: Россия
Разрешение на работу: Россия
Желательное время в пути до работы: Не имеет значения
