* Adhere to FDA/ GCP/ICH requirements
* Design, plan, and implement study protocol(s), case report forms, informed consent(s), study manuals, etc.
* Review study records including case report forms, consent forms and other materials; perform site visits to ensure regulatory and study requirements are being fulfilled
* Train oversee, and coordinate CROs/Vendors
* Make sure studies follow study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures
* Prepare, negotiate, and adhere to the study budgets
* Handle the clinical writing for regulatory submissions
* Maintain and track status reports
* Participate in the development of SOPs
* Mentor junior staff in clinical practive procedures
