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, Ukraine2010
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