Kay Monroe
Specialties: Quality, Management, Regulatory
Biography
Kay Monroe is an industry consultant working for her own firm, Cayman Scientific Consulting, LLC, now based in Connecticut. She has extensive experience in R&D across multiple therapeutic areas and specializes in Project Management roles. Her career includes roles as a Global PM for the development of a drug for diabetic neuropathy and for a novel cardiovascular therapy, implementation of a Project Management Office for a combination drug/device firm, support of migration, validation and documentation for A RIM solution and Global VP of Operations for the US Division of a Danish company focused on CNS therapies. Kay has also worked with multiple non-profits and for-profits working in malaria drug development.
Kay currently works with several start-up companies developing psychedelics for psychiatric and neurological disorders and supports them in different roles. For some she is Acting Chief Operating Officer, for others she is a Clinical Development and Organizational Consultant. Kay holds a BS in Animal Science from UC Davis and an MBA from Golden Gate University in San Francisco.
Courses
- Clinical Document Management - A Trial-by-Trial Approach to Compliance
- Clinical Trial Project Management for Phase 1 thru Phase 4: Best Practices
- CRO, CDMO and Non-Clinical Vendor Management Fundamentals
- Effective Document Management for the Pharmaceutical, Biotech & Medical Device Industries
- Technical Writing for Pharma, Biotech and Med Devices
- Writing Effective Standard Operating Procedures and Other Process Documents