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Project Management and Outsourcing

X498.1 (1 semester unit in Public Health)

A required course in the Professional Program in Clinical Research Conduct and Management

For successful project completion, proper planning and management are essential. This course reviews the principles of project management; allotment of time, finances, and resources in project planning; contingency planning as an essential part of preparedness for situations that deviate from the original plans; and the process of vendor selection, including preparation of requests for proposals (RFPs) and review of vendor proposals.

The course also covers biotechnology project cost and timeline management, including variance analysis; management principles for successful attainment of milestones and project completion; and vendor management.

Prerequisites: Module A: Introduction to Clinical Research and Module B: Clinical Trial Planning and Preparation.

There are currently no sections open for enrollment.

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Sections closed for enrollment

Sat. Sept. 12, San Francisco

JOY BARNITZ, Ph.D. PMP, has extensive experience in new product development in the pharmaceutical, biotechnology and medical device industries. She has managed cross-functional teams developing small molecules, vaccines, therapeutic antibodies, and protein products. In addition, she has established "right-sized" project management processes and systems in several companies.

MADELINE MILLER, D.V.M., is responsible for the implementation of post-marketing research programs in support of anti-viral and anti-infective products at Gilead Sciences. She also supervises the Clinical Finance and Contracts group, supporting all phases of clinical research.

LIZ WOOL is president and CEO at QD-Quality and Training Solutions, Inc., a consulting firm providing clinical quality systems and training services to sponsor companies, CROs, and investigational sites involved in clinical research. She has 30 years of experience in healthcare, including 18 years in the product development industry.

• 2 meetings
• Sept. 12: Sat., 9 am-4 pm (no meeting Sept. 19); also
  Sept. 26: Sat., 9 am-5 pm
  
• San Francisco: Room 807, UC Berkeley Extension Downtown Center, 425 Market St., 8th Floor (enter on Fremont St.)
• $860 (EDP 401687)

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