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gcp edc clinical trials ich oncology📋 Description
- Manage clinical elements: site start-up, enrolment, monitoring, data cleaning, close-out.
- Lead CRAs and oversee trials across multiple countries to ensure timelines and quality.
- Ensure regulatory docs and ongoing oversight; collaborate with cross-functional teams.
- Mentor and train team members.
- Identify timeline risks and offer action plans.
- Maintain study focus via cross-functional partnerships to satisfy clients.
🎯 Requirements
- Bachelor’s degree in science/health field; oncology experience.
- Proven multi-country trial leadership in CRO/Pharma/Biotech (clinical lead).
- Significant oncology clinical trial management experience.
- GCP/ICH knowledge and clinical development process.
- Available for domestic and international travel.
- Proficient with MS Office, CTMS, eTMF, EDC, IXRS.
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