- Develop and maintain clinical project plans, timelines, and budgets
- Lead site feasibility assessments, selection, and CTA negotiations
- Prepare and review study documents like protocols, ICFs, CRFs, and study manuals
- Oversee site initiation, monitoring, and close-out visits
- Manage clinical data activities, including query resolution and data cleaning
- Ensure study compliance with 21 CFR, ISO 14155, and GCP
- Author and review clinical study reports and periodic safety reports
GCP