Our previous posts in this series reviewed the history and evolution of Medical Affairs departments in the pharma industry, noting how the growth of these departments led to an increasing need for project management expertise. We then explored the ways that project management can provide value to Medical Affairs, such as:
- Leveraging assets and maximizing budget efficiencies
- Providing creative approaches to project planning and implementation
- Serving as a communications hub and keeping stakeholders informed about project status
These and other project management activities all have the potential to help Medical Affairs deliver positive results for the organization as a whole. However, the above examples also demonstrate something else: that, even when the organization’s and the department’s overall results are positive, it may not be easy to objectively measure the value provided by a function like project management.
For example, how do we know if the manager has fully leveraged departmental assets? Is it possible to accurately judge the manager’s level of creativity in the planning process? How can we ascertain if a manager is communicating with maximum effectiveness?
Finding objective answers to these types of questions can be quite challenging. And, even in cases in which results can be quantified, it can be hard to know how much control a project manager has over specific aspects of individual outcomes.
What’s more, there are many different teams in the Medical Affairs setting, and perspectives can vary from team to team. While one group may see great value in a project manager’s efforts, others may see things differently.
Given that the perceived value of project management can be very subjective, it makes sense for Medical Affairs departments to try to use as many objective measures as possible when evaluating a manager’s performance.
An opportunity for accountability
When seeking ways to gauge the value of project management in Medical Affairs, the business case and related project plans provide benchmarks that are readily available to most teams.
The business case is the argument made at the outset of each and every project that the task is viable; that the core business benefit is worth the investment; and that the opportunity outweighs the potential risk. It is a presentation that outlines the path the organization should take to achieve that specific core benefit.
When leadership agrees that the business case is viable, it signifies the belief that the chosen path is the best of all available options. And, once the business case is accepted, a project plan is then created, offering all of the detail needed to travel down that path.
From that point, Medical Affairs project managers typically become responsible for checking that the path is being adhered to—that the plan is being followed—as rigorously as possible.
These types of plans are filled with schedules, milestones, budget projections, etc. So, if the organization wants an objective means of holding people such as the project manager accountable, project plans can provide a wealth of opportunities.
When measurement is a challenge
Schedules, milestones, budgets and other objective measures are vital when assessing the value provided by project management. But other aspects of project management can be much harder to gauge.
Take quality control. Good manufacturing practices provide objective tools to determine the quality of a product’s manufacture. Unfortunately, that kind of cut and dried quality evaluation isn’t available when considering essential, yet highly subjective, concerns such as the satisfaction levels of a department like Medical Affairs.
Experts say that team satisfaction is among the most important of all success criteria, and project managers are often responsible for managing and maintaining the satisfaction levels of internal Medical Affairs teams—and sometimes external groups as well. For example, project managers can help to ease the traditional tensions between Medical Affairs and the Commercial arm.
But how do we objectively gauge quality in those arenas? Surveys and interviews are often used to rate satisfaction, but given an environment where project managers have so many tasks involving so many teams, these tools may not be fully able to assess the quality of the manager’s performance.
Yet we can’t deny the importance of gauging satisfaction. Simply put, a project manager is unlikely to succeed if he or she is unable to satisfy the department’s teams. In this situation, leadership may have to take more of an “I know it when I see it” approach instead of using any objective measures.
It’s interesting that it’s sometimes possible to determine external levels of satisfaction—also highly important to Medical Affairs—more accurately than that of internal teams. And, in many cases, external customer satisfaction can be generally reflective of a project manager’s effectiveness.
For Medical Affairs, external customers include the product adopters (providers, payers and patients), so we can use product utilization as one measure of their satisfaction. However, even this gauge may not always be reliable. What if the product is well-utilized in markets where organizational communication is highly effective, but is poorly accepted by audiences we have trouble reaching? Is the problem with the product or the promotion? Or is there another intervening issue entirely—a high amount of competition in that market, for example?
Living with uncertainty
The reality is that all clinical projects contain some degree of uncertainty. Despite this fact, sometimes Medical Affairs—and specifically project management—may be faulted when circumstances are actually beyond their control. Consider recruitment-based study delays, or investigator scheduling conflicts. These obstacles can frustrate a project manager’s best attempts to meet pre-established deadlines, yet he or she may still be held accountable.
And, even when every aspect of the clinical process proceeds unimpeded, there can be disagreements within Legal, Regulatory and Compliance teams; or, when they all agree, the Commercial department may opt for a different approach.
As one Medical Affairs project manager has said, “Some things just have to be lived with,” and the planning process needs to accept the reality that uncertainty is an inevitable part of the clinical function.
Many leading organizations recognize that objective standards are hard to come by in many aspects of project management. They know that any assessment of project management’s true value should take all of these factors into account.
Clearing up the picture
Researching the value of project management in Medical Affairs leads us to see that, while objective measures should be employed whenever possible, project managers often provide significant value in less tangible ways. Project management can be more art than science, and some aspects of the project management field seem to defy measurement entirely.
We would like to offer a few of the questions organizations can ask to gain a clearer picture of project management effectiveness:
- Are the priorities set by Medical Affairs leadership being achieved, on time and on budget?
- Does the project’s progress consistently match departmental business requirements?
- Is the project manager’s performance adaptable in changing situations?
- Are shifts in departmental needs and the overall project environment being effectively anticipated and responded to?
Finally, it’s vital to keep in mind that Medical Affairs is ultimately focused on the patients’ interests. This means that, in the end, the organization’s success, the department’s success, and the project manager’s effectiveness, can really only be proven by the way the product is received by providers, payers and, most of all, by patients.
Positive results come from extensive experience
Given the complexity of the project management function in Medical Affairs, experience really counts. Over the years at CMK Select, we have managed countless pharmaceutical projects. We have met the most difficult challenges, and we have implemented tried and tested systems that consistently deliver excellent results. We are happy to share our expertise, or you can engage our highly-trained, expert staff. Either way, you and your Medical Affairs department will benefit. Contacting CMK Select will boost your success, now and in the future.