Related skills
clinical trials trial management oncology ich-gcp regulatory compliance📋 Description
- Oversee international trials, delivering timely, high-quality data.
- Develop and execute plans for oncology trial operations.
- Collaborate with cross-functional teams to ensure data quality and timelines.
- Manage trial start-up: site selection, feasibility, and documentation.
- Ensure regulatory compliance (ICH-GCP, FDA) throughout the trial lifecycle.
- Lead study master file creation and Sponsor Master File reviews.
🎯 Requirements
- Bachelor's or advanced degree in a relevant scientific discipline.
- 3+ years in Clinical Operations; oncology trials preferred.
- Knowledge of ICH-GCP and FDA guidelines in oncology.
- Experience managing trials from start-up to closeout.
- Strong project management and stakeholder communication skills.
- Proficiency with Veeva CTMS; familiarity with oncology terminology.
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