Global Study Manager CVRM
On-siteWarsaw, Mazovia, Poland
Job Summary
Oversee clinical study delivery from protocol development through archiving, ensuring adherence to ICH GCP, AZ SOPs, and global project frameworks. Lead preparation of delegated study documents and master agreements while managing interactions with internal functions, external partners, and CROs to meet time, cost, and quality objectives. Facilitate investigator and monitor meetings, verify Trial Master File quality, and manage investigational product supply. Contribute to risk identification and mitigation, support budget management and invoice reconciliation, and provide oversight for outsourced studies to ensure alignment with agreed timelines and standards.
Required Qualifications
- University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research
- Relevant experience from within the pharmaceutical industry or similar organization or academic experience, preferably of at least 3 years
- Knowledge of clinical development / drug development process in various phases of development and therapy areas
- Excellent knowledge of international guidelines ICH/GCP
- Excellent communication and relationship building skills, including external service provider management skills
- Good project management skills
- Demonstrated ability to collaborate as well as work independently
- Demonstrated leadership skills
- Computer proficiency, advanced computer skills in day-to-day tasks
- Excellent verbal and written communication in English
Desired Qualifications
- Advanced degree
- Experience in all phases of a clinical study lifecycle
- Basic knowledge of GXP outside of GCP (i.e GMP/GLP)
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