Performed or coordinated external clinical studies of software systems for consumer and professional diabetes management, including site selection, protocol development, site monitoring, closeout, etc.Prepared protocols, reports, and requirements trace matrices, plus any publications needed for launch.Maintained communication with study investigators to ensure studies were completed on time and ensured agreed-upon objectives were met.Worked with investigators to resolve discrepancies.Ensured that studies adhered to FDA regulations, ICH guidelines, Good Clinical Practices, ISO standards, and IVD/MDD directives.

Performed Software Verification and Validation for pharmaceutical and medical device manufacturers.

Served as Testing team lead in the creation of test plans, traceability matrices, test cases and scripts, and managed defect tracking for a variety of client engagements.

Project Manager and Senior Systems Analyst for one of the oldest software companies in long term healthcare.Responsible for the design, development, testing and rollout of enhancements to Payroll, Accounts Receivable and Payable, General Ledger, Medical Records, Resident Assessment, and Care Planning applications.Wrote functional and technical requirements.Created test plans and test cases and scripts, and assisted testing personnel in test execution.Provided high-level support for Customer Service and Technical Support personnel in troubleshooting client problems.Worked with Federal and state government and intermediaries to ensure compliance with regulations.

Supervised and assisted support staff in resolution of client software and hardware problems.Coordinated training of clients and personnel.Analyzed, tested, and documented new software products and enhancements.Developed and taught courses in system administration and applications.