Responsible for creating and managing country level start-up timelines for US, Puerto Rico and Latin America. Manage a team of country specialists who maintain site level activation timelines and collection of essential documents.Work with cross functional teams to address informed consent review, contract execution, IP shipment, study system access and clinical supply shipments.

Provided customer-focused leadership in managing multiple Phase II through Phase IV clinical research trials across functional areas. Accountable for the successful completion of all assigned projects where success includes all of the following: on-time, on-budget, in compliance with all applicable regulations, quality data and reports, and most importantly a satisfied customer.

Responsible for overall management of multiple assigned clinical trials. Coordinated and completed clinical documents including protocols, amendments, informed consents, clinical study reports and scientific posters/presentations.

Managed clinical trials from protocol development through implementation to database lock. Participated in NDA document preparation for submission of novel cox-2 inhibitors.Participated in FDA Advisory Board Meeting for Celecoxib Long-term Arthritis Safety Study (CLASS) sNDA.

Managed a staff of 4 full time study coordinators. Responsible for all IRB submissions and maintenance all regulatory documents for all ongoing clinical trials. Responsible for all trials and back-up coordinator for all trials.

Managed all clinical aspects of the office including stress testing and health evaluations for municipality 'fit for duty' testing as well as wellness visits for corporate clients. Also performed study coordinator duties for smoking cessation clinical trials.

Developed, implemented, and directed Phase I Cardiac Rehabilitation step program for medical and surgical cardiac patients.