Senior Project Specialist
Taipei
- Participated in clinical trials from study initiation to closeout, successfully obtaining NDA approval from the FDA for one study.- Collaborated with Clinical Operations, Data Management, Biostatistics, and the clinical supply and logistics team for project setup, maintenance, and closure.- Coordinated the delivery of SOPs (Standard Operating Procedures) lists, the Project Management Plan (PMP), and the Risk Management Plan (RMP).- Oversaw the qualification of project-specific… Show more - Participated in clinical trials from study initiation to closeout, successfully obtaining NDA approval from the FDA for one study.- Collaborated with Clinical Operations, Data Management, Biostatistics, and the clinical supply and logistics team for project setup, maintenance, and closure.- Coordinated the delivery of SOPs (Standard Operating Procedures) lists, the Project Management Plan (PMP), and the Risk Management Plan (RMP).- Oversaw the qualification of project-specific training for team members.- Provided support during audits and inspections.- Ensured the compliance with clinical trial management systems and the trial master file system.- Proficient in Microsoft 365 tools, including Excel, Word, PowerPoint, and Teams. Show less