1. Ensure the clinical trials are managed in an effective, reliable, timely, and competent fashion.
2. Oversee and/or manage external service providers (e.g., CRO, central laboratory, etc.,).
3. Coordination/cooperation with CRO on clinical project management.
4. Perform on-site co-monitoring visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.
5. Monitor any identified site and clinical trial operation issue, and immediately report to the supervisor with solution recommendations.
6. Monitor and maintain ICH-GCP compliance
7. Excellent presentation and communication skill.
1. Regulatory submission strategy and timeline planning.
3. Being responsible for preparation of TFDA/IRB required document for
submission, including comment reply and obtaining TFDA/IRB approval.
1. A PhD or MS degree in Chemistry or Pharmacy
2. Background in organic/medicinal chemistry
3. Ability to conduct syntheses and subsequent purifications efficiently and independently
4. Hands-on experiences in analytical chemistry and instruments (IR, NMR, GC, HPLC, LC-MS, XRD, etc.)
5. Excellent communication and organization skills