COG West Coast: Applying Theory to Practice, Jess Thompson

In early November the Pharmaceutical Business Conference Group hosted the inaugural COG West Coast meeting in Burlingame, California. Jess Thompson, Founder of the Association of Clinical Research Project Managers, presented on the shortfalls in project management in the clinical research field.

Jess's presentation focused on applying project management principles to clinical research studies, which are complex projects with multiple stakeholders. Some of the key takeaways included below:

• Clinical research professionals often take on project management duties without formal training. Methodologies like Waterfall, Agile, and Hybrid approaches provide frameworks to manage scope, timeline, budget, quality and stakeholders.

• The "triple constraint" balances scope, time, cost and quality. Changes to one impacts the others. Stakeholders must be actively managed based on their interest and influence over the project.

• Effective communication across the many project team members and stakeholders is essential but challenging with so many potential channels. Risk management and timeline management require proactive planning.

• Work breakdown structures, critical path analysis, Gantt charts and lessons learned help map project tasks, schedules and continuous improvement. Ongoing status reporting aids stakeholder alignment.

Clinical research involves complexity warranting a projectized approach to ensure efficient execution and quality outcomes. While sites teams possess deep therapeutic experience, project management training tailored to clinical trials allows professionals to complement scientific knowledge with tools to enhance timelines, resource allocation and stakeholder engagement.

Learn more about the Association of Clinical Research Project Managers mission and access their resources at https://acrpm.org/