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clinical trials oncology veeva ctms fda📋 Description
- Oversee international clinical trials; ensure timely, quality data.
- Develop and implement operational plans for oncology trials.
- Collaborate with data management, regulatory, and investigators to ensure ops excellence and fast data.
- Lead trial start-up; coordinate site selection, feasibility, and docs.
- Monitor study progress; identify risks and implement corrective actions.
- Ensure ICH-GCP and FDA compliance throughout the trial.
🎯 Requirements
- Bachelor's or advanced degree in a relevant scientific discipline.
- Minimum 5 years in Clinical Operations; oncology trial exp preferred.
- Deep knowledge of oncology trial regulations (ICH-GCP, FDA).
- Experience managing trials from start-up to closeout.
- Strong project management; prioritize tasks, allocate resources, manage timelines.
- Proficiency with Veeva CTMS; understanding oncology therapies.
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