BRIGHT study leads are the best at what they do, and one reason is the support they receive from other team members. Like most clinical research organizations (CROs), we employ experts in study design, execution, and site management. In addition, we have dedicated business project managers who help with every study. We believe that investing in this extra layer of support ensures robust communication, timeliness, consistency, and professionalism across all projects, benefiting our study leads, project team members, clients, and clinical site personnel.
Why is the business project management role value-added, and how does it differ from the role of study lead? We’ll answer these questions, and we’ll also discuss the activities handled by this support team as we explore the four Ps of business project management.
The Value-Added Role of Business Project Management
It’s not good business practice to have the same person who performs surgery also run the entire hospital. Surgeons who are bogged down with day-to-day business and patient management logistics can’t be at their best for their most important role, performing surgery. Knowledgeable and focused surgeons provide the best outcomes for patients. That’s why hospitals employ support staff to order products, manage patient scheduling, send bills (arguably not the patient’s favorite part), and handle the myriad other administrative tasks.
We apply this same concept in the way we manage studies at BRIGHT. We believe in having the right people with the right focus in the right places. While our study leads and business project managers are all invested in client relationships and success of the study, our business project managers focus on the project scope, schedule, and budget so that our study leads can focus with surgical precision on supporting the sites to execute a timely and compliant study.
In a nutshell, project managers “manage the project,” and study leads “manage the study.”
The Four Ps of Business Project Management
Our business project managers are an integral part of our study teams, from the very start through the finish line. These team members have visibility to all projects at a high level and are well-versed in the regulatory and quality requirements of clinical studies; this provides a great vantage point to suggest ideas and solutions that help study teams scale and balance project priorities. What exactly do they do? Let’s dive deeper to explore the four Ps of business project management.
All projects begin with a plan, and we project managers love to use our geeky planning tools. Who can say that about a Gantt chart or PowerPoint? When you think you can’t, Gantt! First things first, though; we assist with the necessary business of executing contracts and developing budgets. The statement of work is a key part of this process because it provides the outline for our project plan. Once that structure is outlined, we dive into the juicy details to identify and gather resources and build out the study schedule. We love to organize chaos. And yes, it does feel like a power rush to assign responsibilities and due dates.
Once the study team begins to execute the study schedule, we’re right there with them to manage project-related administrative tasks. We schedule meetings, record and route meeting minutes, and create routine communications about study progress, risks, and performance toward study goals. We also communicate directly and routinely with our client as well as our own internal executive team, providing key dashboard data (e.g., budgets, resources, performance, progress) to all stakeholders to ensure they have a pulse on each BRIGHT-managed study.
We watch our client’s budget like it’s our own checkbook, and if the budget, schedule, or other study trends are off track, we sound an alarm before the train runs off the rails. We’re always looking ahead, focused on what’s required to meet upcoming milestones and the final target. We are also efficiency geeks who routinely use and improve our established processes and templates to optimize productivity and compliance.
Even the best laid plans are likely to encounter divots (or even deeper challenges), and no one can pivot around those divots like a professional project manager. Because we work on all studies, our big picture perspective helps us quickly identify problems, propose solutions, and even impart learnings from other projects. For example, we might help to balance resources, step up communications, or conduct change impact assessments so the study lead can focus on supporting investigators, sites, and study team members.
Project managers work together to compare notes on the happenings across all studies, which allows us to suggest who should be on the team, when a new team member should be plugged into a study, and where to place the right people in the right place. Due to our deep involvement in study logistics, we also serve as a natural backup for the study lead without being redundant, such as covering for illness and vacations. BRIGHT clients always have someone to support them at a management level, someone who can keep the team moving forward.
During the study, we continually review site activations, enrollment status, and other study trend data to assess the impact of necessary adjustments against the overall project scope, schedule, and budget. When problems are identified, or even anticipated, we connect the right team members, executives, and/or client personnel to identify the root cause and facilitate quick and effective preventive or corrective actions.
A common saying by medical device quality folks is, “If it’s not documented, it didn’t happen.” As project managers, we demonstrate, or prove, how things are really going with the study. We do this by providing consistent, reliable, and accurate communications in multiple formats that are customized to the target audience. For example, we report key performance indicators (e.g., site activations, subject enrollments, protocol deviations) to the study leadership team, record and distribute meeting minutes to team members, and provide routine financial updates to client and BRIGHT executives. Not only do we report this information, but we want people to really look at it, so we take great pride in making our communications clear, understandable, and visually appealing.
Don’t let your project manage you. Manage your projects with the right teams that have the right focus in the right places. The secret sauce to accomplish this goal is to have business project managers focusing on the four Ps (plan, perform, pivot, prove) so study leads can focus on managing the study. Our experience demonstrates that an investment in project management is an investment in the success of our clients.