Key Components of Strategic Clinical Research Operational Planning

This web seminar will examine the concepts and applied techniques for cost estimation (PERT analysis, bottom-up, top-down, etc.), budget development, risk management, and quality assurance for clinical research projects. Project management principles and methodology are provided with a special focus on planning, controlling, and coordinating individual and group efforts. Key topics include organization strategy and project selection, defining a project, developing a project plan, scheduling resources, risk analysis, work breakdown structures, project networks, process mapping, and building high performance teams. The needs of project managers who aren’t familiar or experienced with the technical tasks involved in clinical trial management will also be discussed.

• Apply an in-depth understanding of infrastructure in clinical research and clinical operations in biopharmaceutical companies and clinical sites
• Develop skills for strategic planning of clinical trials
• Perform cost estimation for a project and develop schedule for completion of milestones
• Establish systems for quality control and monitoring of clinical trials
• Identify resources needed to complete projects and reasons to outsource
• Determine roles and responsibilities for a clinical trial and develop a communication plan
• Collect performance metrics and use them to improve project success
• Identify and manage risks of clinical trials

• Project Managers with little or no drug development or clinical trial experience
• Sponsor and CRO Personnel involved with the management of clinical trials
• Clinical, Regulatory, and Department Staff who design clinical trial programs
• Clinical Research Associates
• Data Managers
• Team Leaders
• Personnel interested in transitioning into clinical trial management

Marina Malikova, Ph.D., M.S., M.A., C.C.R.A.

Click here for complete trainer biographies

$695

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 2 hours (0.2 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#: 0778-0000-15-030-L01-P. Released: 3/15. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.