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Project Manager, Clinical Trials

Location:
Poway, CA, 92064
Salary:
open
Posted:
August 18, 2010

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Resume:

HARVEY E. STERN

***** ******* ****** • Poway, CA 92064

Phone: 858-***-**** • Email: w0u3sr@r.postjobfree.com

SUMMARY

High energy professional with significant experience in medical project management and high tech marketing. Significant experience in financial management in the health care environment. Possess proven abilities to analyze business processes and markets; excellent leadership, project management, and team building skills.

PROFESSIONAL EXPERIENCE

SCRIPPS HEALTH, SAN DIEGO, CA 9/2009 -- 1/2010

Sr. Project Manager/Wireless

Managed two cardiac device trials. Reviewed and modified the protocols and consents. Helped provide patient data to drive protocol design. Wrote draft CRFs, DSMB and Executive Committee Charters. Initiated CRO contracting and bid evaluation process, RFP development. Responsible for budgeting and financial management.

KAISER PERMANENTE, SAN DIEGO, CA 2005 – 5/2009

Sr. Project Manager/Department Manager, Oncology Research

Managed the KP Adult and Pediatric Oncology Research Clinical Trials programs for all Southern California; Financial Management of $4.5 Million Dollar budget included development of annual budgets for research programs, pharmaceutical contract budgeting and contract negotiations. Responsible for ensuring regulatory compliance, financial management, interface with pharmaceutical companies, and management of staff. Supervised 44 research nurses and research associates, two research pharmacists. Implemented Imedris clinical trials management system and participated in developing research department work flows for Health Connect.

• Program won ASCO 2008 Clinical Participation Award

• Member, Advisory Board UCSD Oncology Clinical Trials Certificate

EDUCATION & TRAINING ASSOCIATES - Poway, CA 1987 - present

Consultant, Management Analyst

ETA performed various consulting activities stemming from the research, interpretation, evaluation, and interrelation of market research data to provide input into the strategic decision making of various client corporations.

• Analyze and advise small businesses to help them to control costs and improve profitability

• Wrote the marketing section for several Mergers & Acquisitions for an Orange County financial company.

• Delivered High Tech Training (Engineering and IT) for various military and industrial clients.

• Managed the development and marketing of new web based products for 1Parkplace, a web services firm serving the Real Estate industry.

• At QUALCOMM performed market research on a competing technology to CDMA which contributed to the decision to acquire Flarion Technologies, Inc

UNIVERSITY OF CALIFORNIA, SAN DIEGO - La Jolla, CA 1996 – 2003

Director, Program and Research Development, Global Strategies 2002 - 2003

Reporting directly to the Dean, responsible for development of the marketing strategy, international outreach opportunities, program management of three grant programs, and worked with various economic development groups from other regions (i.e., El Paso, TX; Philadelphia, PA; Shanghai, China; etc.) to perform research and consult in regional development.

Director, Information Technologies Department 1996 - 2002

Financial Management of department $6M annual budget; Responsible for market research and developing the strategic focus of the department; My business analyses and projections drove marketing campaigns with a budget of 1M annually. Supervised staff of 25 including: 4 program managers, 15 administrative staff, and 6 technical staff. P&L responsibility; Convened and led over 30 high-level industry advisory boards annually.

• Principal architect of strategic and tactical plans for product, marketing, service and systems to meet annual revenue and operating income goals. Results:

o Increased enrollments to 12,000 annually.

o Achieved revenue growth from $1.25M/year to $6.5 M/year, over 400%.

o Increased Net Revenue to 38% ($2.5M).

o Named UCSD Extension Department of the Year in 1998.

o Largest revenue and the largest net contributor in UCSD Extension history.

• Researched and presented business plan to develop an in-house Distance Learning Group at UCSD Extension. Led team effort, co-authored winning proposal for a $130K grant from NTIA, exceeding planned revenue targets. The DL business unit now generates $500K annually -- producing positive income generation 1 year ahead of schedule.

• Completely revamped program -- developed over 30 new Certificate Programs, hundreds of courses.

• Invited contributor to S.D. Workforce Partnership Annual Workforce study: San Diego's Software and Computer Services Industry Cluster: A Strategic Workforce Development Plan 2001-2003.

• Developed and maintained positive business relationships with a number of industry and academic organizations, establishing Joint Venture Educational Alliances with SAIC, Mira Costa Community College, SSQA, IEEE, AEA, and the UCSD School of Engineering.

UNIVERSITY OF CALIFORNIA, BERKELEY - Berkeley, CA 1992 - 1996

Continuing Education Specialist (CES)

Developed and managed entire South Bay Engineering program. Responsible for market research and development of new technical courses, and supervised the implementation of 224 courses per year.

• Generated $2.9M in gross revenues FY 1994-1995. Berkeley Extension’s top producing CES.

• Created the concept and lead the team that developed and presented the 1993 Technology Summit with high-level UCB and Stanford faculty, tech industry CEO’s, and high-level government officials including: Vice President, Al Gore, Secretary of Defense, William Perry; Secretary of Commerce, Ron Brown.

• Team Leader to develop interactive video-based instruction under grant from Pacific Bell. Co-authored grant for $250K. Later, named team leader for U.C. Berkeley Extension effort, EXTEN, in new instructional technology, encompassing on-line instruction, video, CD-ROM, and Worldwide Web Delivery.

UNIVERSITY OF CALIFORNIA, IRVINE - Irvine, CA 1989 - 1992

Program Representative III

Planned, developed and administered short courses in the U.S. and Europe. Generated revenues in excess of $1M annually; expanded in-house revenues by a factor of 10. Member, Advisory Committee for the Competitive Manufacturing Operations Certificate.

INSTITUTE FOR INTERNATIONAL RESEARCH - Beverly Hills, CA 1986 - 1987

Vice President, Program Development

Performed market analysis & forecast studies, analyzed competitive trends, designed and wrote brochures & press releases, and developed conference product. Responsible for budgets and bottom line. Negotiated joint ventures

with 2 associations and one trade journal. Developed highly successful programs in Computer Security and Aircraft Finance.

OTHER PROFESSIONAL DEVELOPMENT

Lecturer at the Milne School, State University of Albany, Albany, NY

Science Teacher Grades 9-12, Albany High School, Albany, NY

Chemist, Technical Services, Oakite Chemical Corporation, Los Angeles, CA

Manager, Marketing Technology Training Corp., Torrance, CA

EDUCATION

B.S., double major in Biochemistry and Education - State University of New York, Albany, NY

New York State Regents Scholarship Winner.

M.A., Management - National University, Irvine, CA

C.E.S. Management Institute - University of California, Irvine, CA

Management Certificate - University of California, San Diego, CA

PUBLICATIONS / COMMITTEES

Stern, Harvey, and S. Brucker, S. Kita, M. Wilcox, "Going the Distance to Serve Students," NUCEA

Region VI & VII Conference, Oct. 1995.

Stern, Harvey, and C. Lee, M. Walshok; “Philadelphia’s High Tech Workforce Training Capacity: A survey of Philadelphia’s Continuing Education Programs for Biotech and IT Industry Clusters,” May 2003.

Stern, Harvey, and J. Cohen; "Building a Profitable Distance Learning Capability with No Money," Web CT, Impact 2003,” July, 2003.

Vice Chairman, IEEE WESCON Short Course Program, 1995.

Chairman, IEEE WESCON Short Course Program, 1997.

Co-Chair Bio-Informatics Session, Laboratory Automation Assoc. Annual Meeting, 2000-2002.

Panelist, Prevent Cancer Foundation, 2008 Summit on Cancer Clinical Trials

Instructor, UCSD Extension, Clinical Trials Administration Certificate, course on Patient Recruitment

Member, Software and Computer Services Industry Focus Coalition to develop the San Diego Strategic

Workforce Development Plan, 2001-2003.

Board Member, Pomerado School Foundation, 2002-2003.



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