Business System Owner of ICON Biotechs Clinical Trial Management Systems. Oversees system support, business training, enhancements, and testing. Liaises with IT and development to ensure the user interface and process best meet the needs of the business. Ensures project teams are audit and inspection ready at all times, user access is managed, and all validation documentation is on hand.

• Develops TMF Services business strategies to assure internal/external client satisfaction, compliance profitability and adherence with company policies and procedures.• Direct contact for future globalization initiatives to support not only North America but also Europe and Asia Pacific. • Collaborates with Business Development to maintain an effective pipeline of projects using our companies TMF Platform. • Oversees the preparation of critical audits/inspections and presents information relative to the functional area• Maintains familiarity with current and emerging industry practices and regulatory requirements related to TMF Operations• Oversees department wide quality management, ensures accuracy of data collected and determines corrective/preventative actions needed for defects found.

• Responsible for management of remote site monitors conducting off site interim monitoring visits to conduct a risked based review of subject data ensuring safety and compliance.• Oversees resource projections to ensure project teams are consistent with client needs, expectations, and contractual expectations.• Provides a point of internal escalation for resolution of clinical issues and conflicts.• Mange and develop staff to ensure high quality work, performance, and retention of high-quality employees.• Evaluates compliance of assigned Clinical Operations employees with company standards and processes.• Provides leadership and implements services and productivity improvements to ensure optimal utilization of billable staff.

• Primary Liaison with site staff from activation through close out to ensure subject safety and compliance. • Prepares for and participates in investigator and client meetings as necessary. • Escalates project and site related issues per SOP to ensure client and investigator obligations are being met and are compliant with local regulatory requirement and ICH-GCP guidelines. • Ensures an audit ready TMF and site staff are up to date with local submissions, Protocols, IBs, and ICFs. • Analyzes data trends and works with sites to resolve EDC queries, missing pages, follow up items, study supplies, lab kits and IP. • Provides quality review of the site level Trial Master File to ensure an accurate and complete TMF.• Utilizes the Clinical Trial Management System to ensure investigator recruitment activities are accurately tracked• Quality Review of informed consent templates.• Documents site and sponsor contact and study interactions in a timely and professional manner.• Performs study duties in adherence to protocol, clinical management plan, study processes, ICH-GCP and other requirements stipulated on the study.• Kick off Meeting Scribe, traveling to onsite Sponsor locations offering direct support to the project team and recording actions and decisions.

Advanced presentation skills using all programs of Microsoft Office. Experienced in communicating with both administration and members of our local community. Develop engaging lessons to meet the needs of all students. Worked at county levels to review curriculum. Follows all state and federal guidelines on a day to day basis. Team leader establishing weekly meetings. Uses flow charts to analyze student data and find best practices. Evaluated as highly effective among the top Biology teachers in the state with student growth on the End of Course Assessment.

Student teacher host with George Mason University, student observer host, new employee mentor, 7th Grade Life Science collaborative team leader, AVID representative, advanced academic educator, and team taught Special Education teacher.West Potomac High School. 2014-2016 Varsity Wrestling coach

Sole proprietor and General Contractor. Tri-Shire Builders, 2006-2012. Executive officer of a seven man crew; in charge of proposals, invoices, client communications, payroll, design, demolition, construction, and accounting. Followed laws and regulations to meet the standards of New York State Code Enforcement, Workman’s Compensation, Disability and General Liability Insurance.