Related skills
clinical trials oncology fda ich-gcp regulatory compliance📋 Description
- Provide daily oversight for international trials; ensure on-time, on-budget data.
- Develop and execute operational plans for oncology trials in-house.
- Collaborate with cross-functional teams to ensure data quality and regulatory compliance.
- Manage trial start-up: site selection, feasibility, and start-up docs.
- Monitor progress; identify risks and implement corrective actions.
- Ensure regulatory compliance (ICH-GCP, FDA) throughout trial lifecycle.
🎯 Requirements
- Bachelor's or advanced degree in a relevant scientific discipline.
- Minimum 5 years in Clinical Operations; oncology trial mgmt preferred.
- Knowledge of ICH-GCP and FDA guidelines for oncology trials.
- Experience managing trials from start-up to closeout.
- Strong project management, prioritization, budgeting, and resourcing.
- Proficiency with Veeva CTMS.
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