Global Study Associate CVRM
On-siteWarsaw, Mazovia, Poland
Warsaw, Mazovia, PolandOn-siteFull TimeEntry LevelEnterprise
Full TimeEntry LevelEnterprise
Job Summary
Coordinate global clinical study execution from setup through close-out and archiving, supporting the Global Study Director and managers with delegated administrative tasks. Initiate and lead the electronic Trial Master File (eTMF) while maintaining regulatory document collections in ANGEL and tracking study materials. Manage study budgets, payments, and logistics for audits and regulatory inspections, and prepare presentation materials for internal and external meetings. Contribute to process improvements and non-drug projects as agreed with your manager.
Required Qualifications
- Education in medical or biological sciences or discipline associated with clinical research
- Proven organizational and analytical skills
- Previous administrative training/experience
- Computer proficiency in day-to-day tasks
- Develop working knowledge of the Clinical Study Process
- Understanding of the range of working procedures relating to the Clinical Study Process
- Understanding of the ICH/GCP guidelines
- Excellent verbal and written communication in English
- Demonstrate ability to work independently
- Demonstrate ability to work in a team environment
- Ability to prepare presentation materials
- Demonstrate professionalism and mutual respect
- Willingness and ability to train others on study administration procedures
Desired Qualifications
- Bachelor level education (or higher)
- Proven study admin/assistant or relevant experience on a study level
- Experience in clinical study lifecycle
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