Работал в 6 компаниях   12 лет 1 месяц

Медицина и Здравоохранение, Фармацевтика

Clinical Research Associate II

IQVIA

Медицина и Здравоохранение

9 месяцев

03.2022 - 12.2022

  • Performs Initiation, routine Monitoring and Close-out site visits and ensuring data standardsare met.??
  • Ensures that the investigator adheres to the study protocol, current GCP guidelines andregulatory requirements during study conduct.??
  • Supporting in the tracking of subjects enrolment at each trial site, and providing managementwith detailed reports of clinical activities as requested.??
  • Conducting regularly scheduled site management calls with study sites to support the sites’execution according to their responsibilities.??
  • Train site staff on protocol, study related procedures and expectations.??
  • Manages data collected from clinical sites, including diagnostic images and the resolution ofdata queries.??
  • Experienced in CTMS, Medidata, IxRS.??
  • Therapeutic experience includes neurology (Multiple Sclerosis), oncology (Bladder cancer;Urothelial carcinoma) studies.

Clinical Research Associate I, Clinical Research Associate II

Global Clinical Trials

Медицина и Здравоохранение

1 год 9 месяцев

06.2020 - 03.2022

  • Performs Initiation, Monitoring, Close-out site visits and ensuring data standards are met.??
  • Preparation of site visit reports and Protocol Deviation log in required deadlines.??
  • Conducting regularly scheduled site management calls with study sites to support the sites’execution of their study responsibilities.??
  • Reporting study progress, escalating issues related to the protocol according to the Companyand Sponsor timelines and quality.??
  • Follow up on outstanding documents/issues or action items identified during onsite visits andassess progress with action plan to resolve.??
  • Train site staff on protocol, study related procedures and expectations.?? Preparation of submissions and notifications to Ethics Committees/ Regulatory Authorities.??
  • Follow up on investigational product/study supplies shipment.??
  • Preparation and maintenance of Investigator Study File.??
  • Preparing and reviewing Agreements with Investigators, sites.??
  • Preparing sites and Investigators grants.??
  • Experienced in EDC (DATATRAK), ERT, IWRS, MSB, Flex Databases.?? Reconciliation visits to Local Depot.??
  • Assisted in the conduct of internal Trial Master File audit, in accordance with applicable SOPsand regulations/guidelines.??
  • Therapeutic experience includes gastroenterology (chronic pancreatitis), pulmonology(idiopathic pulmonary fibrosis) studies.

Quality Executive

GlaxoSmithKline Ukraine / ГлаксоСмітКляйн Україна

Фармацевтика

4 года 7 месяцев

05.2015 - 12.2019

  • CAPA and Root Cause Analysis.??
  • Audits: Management Monitoring, Independent business monitoring, third-party audits.??
  • Risk management.??
  • Complaints handling.??
  • Deviation handling.??
  • Local Incident management, recall simulation.??
  • Reagents management.??
  • Organization of laboratory control for vaccines and medicinal products.??
  • Maintenance of contracts with laboratories.
  • Maintenance of “Quality Management System”.??
  • CoA verifying of imported medicinal products batches.??
  • “Technical Terms of Supply” and “Quality Agreements” coordinator.??
  • Author and reviewer of department SOPs and perform GAP-Analysis.

Pharmacist

"Dobroho Dnya", Pharmacy

Фармацевтика

2 года 2 месяца

03.2013 - 05.2015

Pharmacy Chief, Qualified person

Lugyny Central Drugstore

Фармацевтика

1 год 5 месяцев

10.2011 - 03.2013

* Management of incoming quality control of medicines;

* Communication with Distributors;

* Organization of operations in drugstore;

* Managing 9 workers;

* Providing drugstore necessary range;

* Storage control of medicines;

* Record keeping and reporting.

Pharmacist

Lugyny Central Drugstore

Фармацевтика

1 год 3 месяца

07.2010 - 10.2011

Ключевая информация

  • PC user: MS Office, Internet, etc.??
  • Knowledge of GCP, GMP, GDP, GSP.??
  • Ability to work on multiple projects at the same time.??
  • Ability to keep tight deadlines and work under pressure.??
  • Flexibility and ability to adapt to changes.??
  • Attention to detail, scrupulousness.

Учился в 2 заведениях

National University of Pharmacy

Faculty of economics and management, Administrative Management

Харьков, 2015

National University of Pharmacy

Faculty of multicycled education, Pharmaceutical

Харьков, 2013

Владеет языками

Английский

выше среднего

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Курсы, тренинги, сертификаты

Pharmacist upgrade training course

Киев, 2019

Дополнительная информация

Водительское удостоверение

category B

Oleksandr

Clinical Research Associate/ CRA/ SrCRA

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Киев

34 года

Активно ищет работу

полная занятость, проектная работа

Характер работы: удаленная работа, гибридная, в офисе/на месте

Обновлено 1 неделю назад