Related skills
gcp edc oncology tmf ich-gcp📋 Description
- Oversees site management to ensure patient safety and data quality.
- Independently conducts site visits (pre-study to close-out) and reports.
- Verifies informed consent and monitors safety and data integrity.
- Updates and maintains trial management tools and status reports.
- Manages site startup activities: feasibility, IRB/EC submissions, regulatory docs.
- Ensures IP inventory, reconciliation, labeling and release.
🎯 Requirements
- Bachelor's degree or international equivalent in related field.
- Minimum 2 years on-site monitoring; 1 year oncology preferred.
- Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint).
- Customer service demeanor; team-oriented and flexible.
- Fluency in English; strong written/verbal skills; knowledge of drug development.
- Travel 60-70% as required.
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