Set strategy for clinical and preclinical documentation programs and led Document Management Team consisting of 5 TMF Specialists, 6 contract Document Specialists and 1 Document Management Intern for a $1.5B rare disease pharmaceutical company. Proactively promoted, facilitated, and verified implementation of good quality practices to improve Quality Management System.

Head of product marketing for Medidata’s flagship clinical technology product, Rave (EDC) as well as Coder (coding), Balance (IRT), Safety Gateway (safety reporting) as well as the Study Conduct solution. Develop, manage and execute go-to-market strategy for marketing/sales enablement materials, promotional programs, events, competitive analysis, positioning, messaging and pricing.

Head of operations for local and global document specialist teams providing leadership and direction to 22 full time trial documentation staff creating a performance-based culture. Developed strategies to address workload or project performance issues, including engagement of external partners  Developed KPIs and metrics to assess and report out new eTMF roles and process enablements.  Developed a TMF documentation quality program to assure integrity and quality of documentation in accordance with and adherence to governmental regulations, company procedures and best practices to ensure submission- and inspection-ready collection.

Developed and implemented Trial Master File strategy to establish an inspection-ready, globally accessible documentation collection.  Led a global MedImmune/AZ cross-functional team in the selection and implementation of a SharePoint-based eTMF for 550 users worldwide. Collaborated with AZ counterparts in selection and implementation of AZ eTMF and eventual systems integration planning.  Led a 3.0M initiative to scan and index 20 years of legacy paper TMF documentation. Participated in Food and Drug Administration (FDA), European Medicines Agency (EMA) and Medicines and Healthcare products Regulatory Agency (MHRA) inspection preparation and responses. Global Clinical Strategy Delivery leadership team member working closely with study teams to proactively address study issues and opportunities. Hired, trained, and managed TMF Archive team and developedt of a comprehensive TMF documentation training program for Archive staff and clinical business partners.

Manager, Records and Content Management (June 2007 – July 2009)Senior Consultant, Records and Content Management (June 2006 – June 2007)Provided comprehensive cradle to grave records management consultation to clients in state and local government. Key projects included: New Jersey PARIS Grant Initiative - Directed teams of records managers to provide records assessments and strategic plans for all municipalities in Morris, Sussex, Gloucester, Hunterdon, and Mercer counties. Supported City of Paterson assessment and authored their 2008 grant application. South Jersey Transportation Authority - Conducted a management audit of SJTA focusing on efficiency and effectiveness of physical office space, inter-departmental communication and overall management. Provided analysis of and recommendations for operations, administrative and organizational functions.  Led 12 month project to develop a multi-year strategic plan for the Pennsylvania Public Television Network. Addressed critical issues such as rapidly changing technology, inequitable funding distribution model, and the impending digital conversion all within a climate of budget reductions. Received Best of the Best partners award for 2007 performance.