Over 20 years of clinical operations experience with drug/biologic/device trials, in small to large size organizations, US and international (including countries in Eastern and Western Europe, North and South America, Asia and Australia) IND to NDA/BLA P1-P3b, Pilot, Pivotal, Investigator Sponsored trials, Government funded programs for TMT, HHS and BARDA. Always functioning with a strong focus on the protection of human research subjects, regulatory compliance and the collection/analysis/submission of the highest level of quality data. Specialties: Training (GCP, ICH, and FDA regulations, preparation for regulatory inspections, program and project management, protocol development and implementation, endpoint assessments, clinical monitoring, vendor/CRO/consultant management, data quality management, SOPs and working guidelines, GCP auditing of Investigator sites and vendors for selection/feasibility etc) Gap Analysis, Auditing, Bringing delinquent sites/CROs/vendors into complianceClinical Program Dev, Clinical Trial Management, Vendor Selection/Management, DMC Management, Pharmacovigilance management, GCP Auditing, reporting and follow up Successful Investigator Meeting (domestic and international) Management and Presentation Staff Development and Mentorship, Clinical Operations representation, participation, and presentation to the FDA (CDER, CBER, CDRH) Central TMF Structure and Org, Budget Management (program and trial) Clin Ops representation to the BOD, Industry Conferences and MeetingsReview of Data Listings, Edit Checks and provide Clin Ops support to Data Management Repeatedly demonstrated success in completing challenging studies with difficult to enroll subject populations on time and within budget.