- Manage clinical trials from vendor selection through Clinical Study Report completion.
- Ensure activities meet quality standards including ICH/GCP requirements.
- Create and implement study-specific clinical monitoring tools.
- Lead identification, evaluation, selection, and oversight of clinical trial sites.
- Author and implement operational plans for study enrollment and site monitoring.
- Review/approve vendor and site invoices and manage study budget.
- Implement and oversee the Trial Master File.
- Lead internal and external meetings including Investigator Meetings.
- Perform ongoing study data reviews and data cleaning.
- Manage trial-level quality risk management and study supply oversight.
Cross-functional Team Leadership