Summary
Overview
Work History
Education
Skills
Languages
Additional Information
Timeline
Generic
Marianna Kurmasheva

Marianna Kurmasheva

Zurich

Summary

Extensive experience in clinical operations both at CRO's and Sponsor's levels.

Previous experience in using Veeva products.

Overview

15
15
years of professional experience

Work History

Clinical Operations Coordinator

Alvotech Swiss AG
04.2022 - Current


  • General Clinical Project Management
  • Support with Veeva eTMF implementation, management and oversight
  • Regulatory inspections (FDA, PMDA), audits
  • SOPs development
  • Training of staff

Lead Clinical Research Associate

Worldwide Clinical Trials
07.2017 - 06.2018
  • Leadership to clinical site management team members from study start through closure
  • Development of study related documents and plans
  • Training and management of CRA team

Clinical Research Associate / Senior CRA

Worldwide Clinical Trials
10.2008 - 07.2017
  • All levels of monitoring visits, site management
  • Regulatory documents review and submission

Education

Bachelor of Science - Law

National Academy of Law
Kharkiv, Ukraine
2010

Master of Science - Pharmacy

National University of Pharmacy
Kharkiv, Ukraine
2008

Skills

  • Clinical Trial Management
  • Clinical Monitoring
  • Project Management
  • Regulatory Inspections
  • Trainings
  • ICH-GCP

Languages

Ukrainian
English
German (Intermediate)

Additional Information

Active participation in volunteer projects supporting Ukraine

Timeline

Clinical Operations Coordinator

Alvotech Swiss AG
04.2022 - Current

Lead Clinical Research Associate

Worldwide Clinical Trials
07.2017 - 06.2018

Clinical Research Associate / Senior CRA

Worldwide Clinical Trials
10.2008 - 07.2017

Bachelor of Science - Law

National Academy of Law

Master of Science - Pharmacy

National University of Pharmacy

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Marianna Kurmasheva