Project manager for the JC Medical J-Valve EFS and JOURNEY Pivotal studies.

- Provide trial support for site management; including payments, protocol compliance, and data collection - Support electronic database entry, verify data accuracy and organize data and file storage - Correspond with sites regarding database entry, source documentation, and monitored action items - Draft and implement SOPs, CAPAs, and site training - Coordinate product order and shipment (usually same day) for Emergency Compassionate cases with sites - Draft and distribute bi-monthly study related newsletter with team input - Assist with training new team CRA - Provide input to protocol design - Assist with physician meetings - Beta test public processes before implementing outside of SJM - Identify and implement improved process efficiencies - Design and implement independent clinical trial review board process for physician submitted studies - Develop and manage web submission form and SOPs for physician trial submission - Organize and manage contracts for physician review board - Provide technical troubleshooting support for many programs including Office, Agile, Clindex, and Adobe

Provides support and guidance to CEO, Sales and Marketing team, and office while assisting with post market clinical study management. - Provided IT technical support related to Microsoft Office and server access, among other issues. - Organized travel itineraries for CEO and upper management. - Processed sales orders, purchase orders and received shipments. - Processed accounts payable data entries. - Designed, resourced and assembled all marketing packages and documentation. - Organized sales and marketing events. - Created and organized Distributor database.

Working with Regulatory to set up, manage, and monitor clinical studies in all aspects. - Assisted with collection and completion of documentation for submission to localized ethics committees and hospitals. - Provided review and critique of CRO supplied Clinical Research Forms and other documents. - Periodically drafted Clinical Research Forms. - Maintained filing and documentation system of Clinical Research Forms. - Drafted and executed international monitoring plan and site training. - Assisted with site GCP training. - Assisted with monitoring. - Prepared all monitoring reports. - Communicated with international sites and CRO. - Reviewed and addressed Data Clarification Requests with sites. - Coordinated data sent to core lab. - Provided critique and review of CRO final report - Assisted with some documentation for US Clinical Trial. - Attended numerous clinical training sessions by Life Science Alley and Barnett International.

Designed and initiated implementation of the corporation quality system. - Organized Quality System documentation system based on FDA regulatory guidelines. - Drafted original documents to fit structural function requirements for company - Supported R&D and Manufacturing documentation organization - Implemented training to documentation

Facilitated separation of IT contracts and licensing previously owned by Guidant Corporation, between divested locations owner Abbott Vascular, and new parent Boston Scientific. - Created and maintained separation process of contracts, services, and licenses on Guidant’s behalf based on individual design, legal requirements, and terms created by the overarching purchase agreement between Boston Scientific and Abbott Laboratories. - Coordinated closely between legacy Guidant employees within both Abbott Vascular and Boston Scientific to collect contracts and their relevant license or service information to determine necessity of separation between corporations, as well as amounts to be separated. - Worked closely with in house and external Boston Scientific counsel, and also communicated with Abbott Vascular and Abbott Laboratories counsel to provide technical conditions for the teams to base their legal definitions for the separation on. - Coordinated between vendor representatives, vendor counsel, Abbott Vascular and Boston Scientific counsel to create agreement between all parties regarding language of separation documents. - Synchronized signature process between all parties, and collected documents completed with all signatures for record within Boston Scientific’s legal department. - Reported regular progress on daily and weekly basis to various individuals from both corporations, including the CIO, directors, and other management.

General Assistant to all management within the office including directors and executives. Consulted on and designed file management systems, as well as maintained many systems within the office. Assisted in completion of assorted projects as needed. Relied upon for various tasks including creating Power Point presentations, reviewing and editing marketing materials, and other general office duties.ACCOMPLISHMENTS:- Aided in the design, creation, and maintenance of the quality documentation file for the quality control department. - Performed quality control inspections of the product.- Designed and created an electronic labeling format for the product.- Involved in the design and maintenance of the purchasing, receiving, and the controls. - Assisted in the IT management, specializing in hardware and troubleshooting. - Created and formatted relevant forms and documentation for all departments.- Maintained a class 10,000 clean room.

Manager responsible for control and direction of the Shakopee Jaycee’s Renaissance Festival Beer Sales Project. Focused on product management, profit growth, and procedure improvement. Communicated regularly with staff and supervisors, also acted to improve working conditions for volunteers. ACCOMPLISHMENTS:- Discovered a new law allowing increase of sales hours to an equivalent of one extra day.- Cut wasted product by 52% over the previous year.- Managed 40 to 100 people at any given time and ten pubs (booths).- Increased income to a record setting high, by over 12% from the previous year.- Minimized inventory to record low on closing day.- Designed and implemented a new system for tracking sales and theft within the pubs for same day accuracy. - Responsible for ordering products and supplies based on previous business forecasts. - Created the first procedures and operations manual for future chair people to use.- Mentored future chair candidates.