This course is an integrative learning experience, combining a comprehensive review of the good clinical practice core principles and project management strategies applicable to clinical research during the new drug development process.
This course examines the concepts and applied techniques for cost estimation, risk management and quality assurance for clinical research projects. Project management principles and methodology are provided with special focus on planning, controlling, and coordinating individual and group efforts. Key topics include overview of modern project management in clinical trials, organization strategy and project selection, defining a project and developing a project plan and scheduling resources, project risk analysis, work breakdown structures, and project networks. Mastery of key tools and concepts introduced in this course and development of the skills vital to effective management of multidisciplinary tasks through lectures, case studies and discussions will provide a significant competitive advantage in the marketplace for clinical research professionals.
- Describe project management as it applies to clinical research and in the management of clinical trials
- Identify how project managers develop high performance project teams
- Develop a project plan and work breakdown structure
- Identify process mapping tools used in clinical research
- Recognize the importance of effective project schedules
- Identify clinical trial project budgetary needs
- Identify performance metrics and utilize effectively to monitor project
- Management of vendors within a clinical trial for optimal oversight and outcomes
- Implement successful project closure and lessons learned
- Prioritization and strategies in planning clinical studies
- Recourses allocation
- Outsourcing strategy
- Assigning role and responsibilities of study team members
- Cost estimation and budgets for clinical project
- Establishing schedules, timelines to meet corporate goals
- Risk Management and Quality Assurance strategies
Who will Benefit:
- New Project Managers
- Project Managers with little or no drug development or clinical trial experience
- Staff from Pharmaceutical Companies or Contract Research Organizations (CROs) involved with the management of clinical trials
- New Clinical or other Project Team Leaders who will be managing projects
- Managers unfamiliar with clinical project management
- New Clinical, Regulatory, and Department Staff who will design clinical trial programs
- Clinical Research Associates, Data Managers or others interested in transitioning into clinical trial management
- Project Team Leaders with limited direct clinical trial experience who will be managing drug development programs and supervising project managers
- Grant Administrators
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Palo Alto, CA 94303
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Your Registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-771-6965 or email us @ firstname.lastname@example.org
Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)
Cancellations and Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $300 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future GRC Seminars event and a credit note will be issued.
Substitutions may be made at any time. No-shows will be charged the full amount.
We discourage onsite registrations, however if you wish to register onsite payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available we will send the material after the conference is over.
In the event GRC Seminars cancels the seminar, GRC Seminars is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.
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