- Experience in conducting global clinical trials by managing multi-functional international study teams in adherence to ICH Guidelines and other applicable regulations
- Expertise in the design, feasibility assessment, and planning of single and multi-center Phase I-IV clinical trials
- Experience in compiling and writing technical documents such as investigational drug brochures, protocols, informed consents, and clinical study reports
- Expertise in qualifying, selecting, training, managing field-based study monitors and medical monitors against clinical trial needs
- Expertise in creating and implementing Monitoring, Audit, Data Management, and Trial Master File plans
- Expertise in investigational drug accountability procedures including for controlled substances