The course builds on project management basics to examine some of the more difficult issues encountered by clinical project managers. It examines approaches for optimizing clinical trial conduct and includes discussion of current hot-button concerns facing clinical project managers.
Develop a more strategic approach to management
Assess trial design decisions
Define best practices
Recognize the use and abuse of metrics
Implement resource planning techniques
Implement risk management techniques
Optimize site selection
Enhance patient recruitment and retention
Cite new issues and technologies in project management
Clinical Project Managers who have mastered project management basics
Experienced Project Managers with limited drug development or clinical trial experience
Team Leaders or Managers with a basic knowledge of clinical project management
Staff from pharma, biotech or CROs who wish to learn more about the clinical trial process
Clinical, Regulatory and Development staff who design clinical trial programs
The course will be led by one of the following instructors:
Tim Krupa, M.S., M.B.A.
Eric Morfin, M.B.A., P.M.P
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Day 1: 8:30 a.m. – 5:00 p.m.
- Strategic Planning and Development: Goals; design; strategy; anticipating
- Trial Design: Study objectives; endpoints; data collection; quality; study populations; protocol
- Resourcing: Sponsors; CROs; forecasting needs; planning
- Risk Management: Process planning; identification; analysis; response; monitoring and control; tools
- Best Practices and Project Management Tools: Standardizing data collection; benchmarking; tools
Day 2: 8:30 a.m. – 5:00 p.m.
- Managing Performance and Improving Outcomes: Metrics; issues; analysis; reporting; standardization
- Investigator Performance: Identifying; performance
- Patient Recruitment and Retention: Identifying; techniques; minority enrollment; retention
- Conduct of International Trials: Culture; diversity; logistics; financial issues; recruitment; international guidelines
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Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Elizabeth Andrews at 781-972-5418 to discuss your options and take advantage of the savings.
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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE# 0778-0000-09-018-L01-P. Released: 8/09.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.