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Female, 49 years, born on 1 December 1976

Saint Petersburg, metro station Ploschad' Vosstaniya, willing to relocate (Great Britain, Moscow, USA), prepared for business trips

Clinical Research Manager

Specializations:
  • Sales manager, account manager

Employment type: full time

Work experience 23 years

March 2022December 2025
3 years 10 months
Data Management 365

Saint Petersburg, dm365.ru

Medicine, Pharmaceuticals, Pharmacies... Show more

Director, QA & Corporate Development
Develop and support the company's QMS (ISO 9001 compliant) Organize the QA & Training department work Manage the staff training and qualification programs Conduct internal and host external audits/inspections Manage vendor selection, qualification, and oversight Review and approve product/service related documentation and deliverables Set up and oversee medical aspects of the data management services
June 2016March 2022
5 years 10 months
Data Management 365

Saint Petersburg, datamanagement355.com

Medicine, Pharmaceuticals, Pharmacies... Show more

Operations Director
Develop and optimize business processes, prepare related documentation. Assess business needs and manage qualified personnel accordingly. Adopt and use a variety of electronic systems (clinical, managerial, supportive), including AI based.
March 2016March 2022
6 years 1 month
Data Management 365

Saint Petersburg, datamanagement365.com

Medicine, Pharmaceuticals, Pharmacies... Show more

Project Manager
Perform the PM role in data management service projects for clinical trials.
April 2015March 2016
1 year

Saint Petersburg, www.wwctrials.com

Medicine, Pharmaceuticals, Pharmacies... Show more

Business Systems Analyst
Overview of all IT systems used by the company Information flows analysis Identification of business needs Gathering and documenting business/user requirements Stakeholder analysis Software vendors selection and assessment
October 2008August 2014
5 years 11 months

Saint Petersburg, www.wwctrials.com

Medicine, Pharmaceuticals, Pharmacies... Show more

IxRS Support Manager, Team Leader since July 2013
Management of IxRS / drug supply projects from go-live to close-out, covering all phases and various therapeutic areas Area Lead and PM roles, Sponsor and vendor facing 24/ 7 Helpdesk Training and mentoring staff Line management for Manager and Assistant roles based in Russia and the UK Preparation of departmental guidelines Presenting at an Investigator meeting and internally Data extraction, manipulation and reporting User acceptance testing Incident reporting and mgmt Proven ability to learn remotely and work independently Consistently recognized as a high performer Praised for proactive approach
September 2006April 2007
8 months
Kemerovo Information Services Bureau, LLC

Kemerovo

Media, Marketing, Advertising, PR, Design, Production... Show more

Special Projects Team Leader
Planned, managed and implemented a start-up project (gift delivery service). Developed and conducted marketing surveys and promo-actions, including multi-brand campaigns requiring collaboration with business partners. Participated in advertisement design and placement.
May 2002September 2006
4 years 5 months
Kemerovo Regional Clinical Oncology Dispensary

Kemerovo, www.kemokod.ru

Medicine, Pharmaceuticals, Pharmacies... Show more

Doctor
Performed endoscopic procedures in the out-patient department and all in-patient departments incl. operating rooms and ICUs: transluminal and invasive (laparoscopy, thoracoscopy), on the purposes of diagnosis and treatment.
June 1998August 1998
3 months
KuzbassCantec

Mezhdurechensk

Mining Industry... Show more

Translator (short-term contract)
Document translation
May 1996May 1997
1 year 1 month
Medical Centre ''General Practice''

Kemerovo

Medicine, Pharmaceuticals, Pharmacies... Show more

Nurse
Patient care in post-surgery wards, delivery of administered treatment, assistance at surgical procedures.

Skills

Skill proficiency levels
Analytical skills
Attention to detail
MS Office
Clinical systems knowledge: IxRS/IRT, eCRF, ePRO, CTMS, Safety database
Teamleading
Presentation skills
Project management
Business Analysis
Водительское удостоверение категории B
Training
Business communication
Due Diligence
Английский язык
Customer Service
Организаторские навыки
Leadership Skills
Деловая переписка
Анализ конкурентной среды
Работа с базами данных
Медицинская документация
Разработка нового продукта
Деловое общение
Работа на выставках
Ведение переписки на иностранном языке
Анализ данных
Научные исследования
ВЭД
Деловой этикет
Market Research

Driving experience

Driver's license category B

Higher education

1999
Higher education
1999
Higher education
Кемеровский государственный университет, Кемерово
Roman and Germanic Philology Department, Philologist, Translator for professional communication

Languages

Russian — Native

English — C2 — Proficiency

Professional development, courses

2025
Medical coding
MSSO, UMC, Regenstrief Institute, MedDRA, ATC, WHODrug, LOINC
2024
Validation of and/or through AI
Propharma Group Validation Center, SaMD
2024
Electronic data integrity
Propharma Group Validation Center, CFR 21 part 11
2023
Electronic systems, electronic records, and electronic signatures
FDA CDER SBIA, CFR 21 part 11
2023
CDISC standards, TMF reference model
CDISC, Clinical trials
2022
GCP auditing
RQA, Clinical trials
2019
Agile and Scrum
Independent coach, IT products
2018
Risk based approach to software quality and validation
Praxis Life Sciences, GxP
2016
Good Clinical Data Management Practice
ZM Company, Inc., Clinical trials
2010
Title 21 CFR Part 11 Compliance
Worldwide Clinical Trials, Title 21 CFR Part 11 Compliance
2009
GCP Course for Investigators
Worldwide Clinical Trials, ICH GCP Compliance
2009
On-the-Job Training
Worldwide Clinical Trials, IVRS Support and Helpdesk
2008
Basic CRA Training
Evidence CPR, CRA
2002
Clinical Residency in Oncology
Kemerovo State Medical Academy, Oncology
2002
On-the-Job Training
Kemerovo City Clinical Hospital #3, Endoscopies, Endosurgery

Tests, examinations

2015
Cambridge Certificate in Advanced English
Language Link, Moscow, CEFR Level C1

Citizenship, travel time to work

Citizenship: Russia

Permission to work: Russia

Desired travel time to work: Doesn't matter