Managing Clinical Trials, Fall 2013
Packaged deals can be arranged when combining Clinical Trial Overview with Managing Clinical Trials Multiple enrollments from a single company will also qualify for additional discounted pricing. Contact Julie Deschenes for more information.
- Completion of MABioEd’s “Clinical Trial Overview” or
- At least 2 years of experience in a clinical trial role (e.g., CRA, PM, CTA)
This modular, 6-session workshop will introduce the major skills needed to manage outsourced clinical studies within a CRO/Sponsor environment. It is intended for those currently working in the clinical trial space and who have some knowledge of the process and flow of clinical research. Case studies and interactive exercises combined with lecture and discussion, will allow participants to take away useful tools and techniques to apply immediately, and to assist them with building their skills in managing outsourced clinical projects in a highly scrutinized regulatory environment.
By the end of the course, learners will be able to:
- Illustrate the study management and oversight process for clinical trials, based on the Project Management Body of Knowledge (PMBOK®).
- Explain the skills, competencies, and behaviors applied by effective project/study managers across the project lifecycle.
- Demonstrate how to encourage and support effective teamwork.
- Apply effective project planning and start-up skills including:
- Identifying and selecting vendors
- Designing and running kick-off meetings
- Participating in defining roles and responsibilities
- Determining project scope and estimating a schedule
- Setting clear expectations
- Planning quality metrics to measure and control progress and performance
- Designing a communication and escalation plan
- Identifying, assessing, and planning for risk
- Facilitating start-up activities
- Detail professional skills that support efficiency and productivity.
- Describe how setting expectations and planning communication supports effective oversight of resources.
- Facilitate the work of the team to execute the project and manage planned vs. actual progress and performance.
- Apply project and vendor management best practices from both the tactical “day-to-day” and strategic “big picture” perspectives:
- Project planning
- Vendor selection and oversight
- Risk management
- Document management
- Negotiation, decision-making, problem solving
- Assessing progress and performance
- Action planning
- Documentation of project oversightInstructor: