Related skills
regulatory submissions etmf ctms capa ich-gcp📋 Description
- Lead planning, conduct and oversight of clinical studies.
- Ensure studies follow protocol, SOPs, ICH-GCP and regs.
- Develop study documents, ICF templates, CRF guidelines, trackers.
- Identify training needs for CRAs and vendors.
- Drive site feasibility and recruitment strategies.
- Oversee IP management and budget tracking.
🎯 Requirements
- Bachelor's degree in science or health; advanced degree preferred.
- 5-8 years clinical research experience; oncology Phase I in Taiwan/China preferred.
- Knowledge of ICH-GCP, regulatory submissions, CAPA.
- Strong communication with investigators and cross-functional teams.
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