Related skills
gcp edc tmf ich-gcp gpp📋 Description
- Oversees site management to protect patient safety and data quality.
- Conducts site monitoring visits (pre-study, initiation, routine, close-out).
- Ensures compliance with ICH-GCP, GPP, and local regulations.
- Maintains trial tools, reports status, and documents actions.
- Supports site start-up: feasibility, recruitment, regulatory submissions, ICFs.
- Manages IP inventory, labeling, and drug accountability per protocol.
🎯 Requirements
- Bachelor's degree or international equivalent in science/healthcare.
- Minimum 2 years on-site monitoring; 1 year oncology experience.
- Global Clinical Trial experience.
- Proficient in MS Office (Outlook, Word, Excel, PowerPoint).
- Fluent English (spoken and written); knowledge of drug development.
- Travel 60-70% as required.
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