Experienced clinical research professional with a Master of Bioscience focused in Clinical and Regulatory Affairs and demonstrated history of working in the both medical device and pharmaceutical industries. Therapeutic areas include CNS/neurology, cardiology, urology, ophthalmology, oncology, and pediatrics.

Specialties:

• Quality management of Clinical Vendors including CROs, Core Labs, Contract monitors, physician consultants, etc.
• Clinical trial planning, execution, and monitoring
• Developing Clinical Strategy and Evaluation Plans
• Pre-clinical study design, planning, and execution
• Interpreting and implementation of US 21 CFRs, ISO, EU MDD, and AU TGA requirements
• Application of GMP, GLP, and GCP
• Protecting the rights, welfare, and safety of Research subjects