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:
Marla Hoelle, R.N, B.S.N., C.C.R.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
- Identifying the Issues
- Risk Management Planning
- Global Case Study on Conduct of Ethical Research
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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 Melissa Dolen 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 issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE# 0778-0000-15-042-L01-P. Released: 8/15.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.