Wendy R. Gries, Ccrp Email and Phone Number

Database management, research and event planning for nonprofit and marketing organizations.

Manager, Clinical Operations (2012 - 2016)Clinical Research Associate (2010 - 2012)•Managed clinical operations for European heart failure trial following international standards and ensuring compliance to Good Clinical Practice guidelines, patient safety and data integrity. •Developed and maintained relationships with vendors and independent contractors, working closely with hospital study teams and imaging labs to improve cost-efficiency, timeliness and mutual support. •Designed and generated clinical study documents, clinical affairs procedures and internal tracking systems providing critical information and detailed reports for immediate access as needed.•Classified and reported adverse events, working with the Data Safety Board for adjudication of serious events.•Lobbied for shift from paper study to electronic data capture system, promoting quicker access to data, data security and accuracy, and cost savings. Integral part of system setup and design.

•Developed marketing material, quotes and capabilities brochures targeting potential hospitals and surgeons for device use as well as heart failure programs.•Oversaw participation in industry conventions and tradeshows, building relationships and raising awareness of the company’s brand and product. •Supported Quality Assurance by managing document control, employee training and vendor/supplier approval, and preparing the company for a successful major quality audit.•Managed relationships with vendors and contractors resulting in cost-efficiency and timeliness, while encouraging a team mentality.