This course focuses on the most difficult skills project managers need to acquire in order to lead their domestic and global clinical trials to optimal performance. It provides the experienced R&D professional with practical and tactical project management information to efficiently manage their projects.
Advanced concepts are introduced building on basic and intermediate project management techniques and essential tools for planning and managing time, efficiently tracking and preventing delays, accurately estimating cost, and developing a clinical trial budget. Communication techniques are thoroughly detailed with the purpose of giving participants the knowledge to get their team members and stakeholders fully committed to their project and to improve the global performance of clinical trials they are managing. Project management best practices for managing contract service providers are detailed. The course provides practical tools and processes but also focuses on useful information for improving sponsor/CRO relationships. The course covers major concepts for managing and resourcing multiple projects. Advanced techniques and processes for clinical research risk analysis, root cause analysis and corrective and preventive action (CAPA) are also presented together with the latest regulatory expectations and guidelines. The course concludes with practical techniques for optimizing the decision-making process and improving R&D productivity. This course is designed to be interactive and includes case studies, quizzes with short role-playing exercises, and sharing of experience.
- Use effective communication techniques with project teams to obtain their full commitment
- Design a performing environment that motivates all stakeholders through clear expectations and consequences
- Build a successful team and manage its performance
- Develop a communication plan
- Master timeline development and monitoring, and track and prevent delays
- Estimate and manage costs
- Learn the basics in managing multiple projects and resource allocation
- Employ project management best practices for managing contract service providers and improving the relationship
- Learn how to use a process for conducting risk analysis for a clinical trial and managing clinical study related risks
- Understand international regulatory expectations for root-cause analysis and CAPA
- Identify and prioritize potential problems, and efficiently implement root cause analysis and corrective and preventive action plans
- Learn a process for making strategic decisions
- Project Managers, Directors, and Leaders
- Clinical Research Investigators, Coordinators, Associates, Monitors, and Managers
- Regulatory, Medical, and Clinical Affairs Professionals
- Preclinical and R&D Directors/Associates/Scientists
- Toxicology, Pharmacology, Pharmacovigilance, and Labeling Professionals
The course will be led by one of the following instructors:
Véronique Lalevee, Pharm,D., P.M.P.
Eric Morfin, M.B.A., P.M.P
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Day 1: 8:30 a.m. – 5:00 p.m.
- Introduction: Reminders of project management essential concepts, overview of R&D and project management processes, fundamental tools and techniques for managing clinical projects, roles and organizations, strategic goals of clinical development and how to develop a clinical trial project plan
- Communication and Performance management: Learn how to influence stakeholders to get their commitment on the study either by acting on their environment and consequences or by using personality profiling; leadership techniques and coaching model to manage the performance of the project team; techniques and useful tips to build a successful team, manage cultural differences on international/global studies and lead virtual teams; developing a communication plan
- Advanced Time Management: Importance of the planning process in preventing delays; timeline management core concepts; developing an accurate study timeline; tracking progress against the objectives and the use of milestones; strategies for accelerating clinical trial timelines
- Cost management: Core concepts in estimating costs; major elements to consider for developing a clinical trial budget; core concepts in tracking, monitoring and scheduling costs
- Managing multiple projects and Project Portfolios: Definition and importance of Project Portfolio management in pharmaceutical and clinical R&D; managing resource allocation on multiple projects
- Project Management Best Practices for Managing Contract Service Providers: Role of project managers in outsourcing studies; current data on sponsor/CRO relationships; guidelines for a successful sponsor/CRO partnership; key concepts for selecting and managing contract service providers; contracts types and risks; types of sponsor/CRO relationships; preparing the efficient implementation of an outsourced trial using a project operating guideline
Day 2: 8:30 a.m. – 5:00 p.m.
- Risk Management: Review of major product risks with GCP most common issues, Misconduct and Fraud; assessing the risks and conducting risk analysis: identifying, prioritizing and preventing potential problems; developing preventive and contingent actions (detailed process and tools are explained); transposing the risk analysis process to the specifics of clinical research to be compliant with the latest regulatory requirements and a risk-based Quality management process (focus on latest European and FDA guidelines and Authorities expectations, and specific clinical trial related risks)
- Root-Cause analysis (RCA) and Corrective and Preventive Actions (CAPA): Regulatory expectations for clinical CAPA; what to expect during an inspection; implementing a CAPA program; practical tools and techniques for performing RCA; communicating CAPA to key stakeholders
- Optimizing the Decision-Making Process: Challenges and levels for strategic decision-making; decision-making framework; agreeing and negotiating objectives; selecting and evaluating alternatives
- Learn to quickly assess the leadership style required by each situation
- Analyze the network of tasks and create a Critical Path for a Clinical Trial
- Identify the root-cause of a quality problem when launching a new pill in several countries
- Select the best packaging for launching a new drug using a strategic decision-making process
- Role-playing exercises related to different modules
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# 0778-0000-15-002-L01-P. Released: 2/15.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.