Marge Woodard Email & Phone Number

Greater San Diego Area & Global

Project manage clinical trials and research programs spanning; site selection, applications, initiation, enrollment, training, monitoring and close-outs in accordance with contracted scope of work and good clinical practices. (GCP/GMP). Conduct monitoring visits and site management focused on Regenerative Medicine, Stem Cell and Oncology Research. Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Liaison with FDA, NCI, IRB's, and Office of Complementary and Integrative Health (NCCIH). Administer Continuing Medical Education (CME) Programs. Participate in the San Diego Regulatory Affairs Network and the Orange County Regulatory Affairs Discussion Group.Projects include: Strategic organization change, process design, software integration, quality systems, training and development.Served on the Board of Examiners for the Malcolm Baldrige National Quality Award (MBNQA) program. Conduct ISO audits and consult in administration of these programs. Implement student internship programs partnering with universities and community outreach programs.

Greater San Diego Area

ACCENTURE (formerly ANDERSEN CONSULTING), Dallas, TexasA $27.9 Billion global management consulting, technology services and outsourcing company. •Led large program teams engaged in organizational change and software systems integration.•Directed organization design for a new Global Procurement Department function impacting 75,000 employees & 300 suppliers globally.•Led program & project teams that delivered training, communications programs, balanced scorecards and e-Commerce systems (People Soft & Ariba). Delivered under budget, on time with $32 million savings.

Appointed to the Board of Examiners. A volunteer position. Served for three years and at the state level for eight years. As an examiner, served on teams that evaluated the performance improvement of all types of organizations—businesses, schools, hospitals, and nonprofit organizations, including government agencies—that are striving to serve as role models by applying for the Baldrige Award.

Carlsbad, Ca And Dallas Texas

Internal consultant. Program director for diverse projects: strategic planning, organization design & development, human resources, political initiatives, draft legislation. Published 2 books. Execute clinical trials, coordinate with the National Cancer Institute & NIH on Best Case Studies; prepare applications to secure grant funding for research & clinical trials.Prepare media responses, communications, marketing materials and website content. Monitor and report on website performance and social media. Develop marketing plans.

Texas Manufacturing Assistance Center-TMAC, at UTA. Conduct strategic consulting, including: Lean Manufacturing, process/performance improvement, organization assessment, strategic planning, workforce development, quality management systems (ISO 9001 & Baldrige), marketing and sales.

Texas

Appointment. A volunteer position applying the Malcolm Baldrige National Quality Award criteria, I support and evaluate the performance improvement of all types of organizations—businesses, schools, hospitals, and nonprofit organizations, including government agencies—striving to serve as role models by applying for the Baldrige Award. I specialize in health care organizations and criteria.

•Initiated and managed design and deployment of an 11-course Continuous Improvement Management System curriculum that supported strategic initiatives. Hired and managed consultants. •Conducted internal consulting by partnering & defining performance improvement opportunities and interventions that improved business results. Coached and mentored executives, employees at all levels. Facilitated process improvement & executive teams. Planned, developed, and delivered competency-based programs.

Masters In Business In Process, Organization Development

Clinical Trials Administration, Health/Health Care Administration/Management, 4.0

Ba & Credential, Business/Sociology/Family & Consumer Science

Activities and Societies: California Standard Teaching Credential BA, MBA in process.