Problem solvers, risk wranglers
By: Catherine de Castro | December 20, 2016
How QuntilesIMS is building an army of project managers ready to tackle every risk that comes their way.
Good project management is essential for the success of any clinical research program. Seasoned project management professionals create an environment where teams are able to work smoothly together, risks are identified and mitigated, and problems are addressed quickly and efficiently to avoid delays.
Many industries rely on formal project management practices to meet their project goals, yet the biopharma industry has been slower to recognize the value it brings to the clinical research lifecycle. A good project management practice can help clinical researchers deliver more efficient and productive trials with less downtime and fewer errors, while delivering higher quality research. It also creates a more collaborative trusting environment where stakeholders work together to problem-solve. All of this translates into better, faster and more cost-effective trials.
But it doesn’t happen organically. It’s easy to assign someone the title of project manager and put them in charge of running the show. But unless they have formal project management training, a framework for project delivery, and the support of a project management organization and governance structure, they cannot be expected to manage the complexities that are inherent to the clinical trial process or deal with the inevitable challenges that arise.
Building a strong clinical project management culture begins with training. We know that our project managers will face a lot of situations in the clinical research environment where they will have to make tough decisions. The training programs offered through our Project Management Center of Excellence give them skills to assess the data they have available and make the best decisions on behalf of patients, the sponsors and the research process.
Most of our courses focus on problem-solving, and use case studies and real-life scenarios, this immersive approach teaches trainees how to use project management best practices to address real-world challenges in the fast-paced clinical research environment.
At the end of the training program, our project managers are paired with a mentor, who provides them with guidance and act as a sounding board as they build their experience and skills in the field. Project managers are also encouraged to pursue further education as part of their career development path, through our own curriculum of soft skills, technical and leadership courses, and by pursuing industry project management certifications, which we support.
On the job, we provide all of our project managers with an integrated project management structure that includes regular stage gate reviews by a governance body, to provide additional oversight and feedback on progress and risks.
Many organizations believe that clinical experience is the only thing that matters in running a clinical trial. But that is only part of the equation. Skilled project managers understand how to translate the clinical trial into a project management framework. That includes building risk registries that evolve as the trial matures, establishing clear communication strategies to ensure all staff and stakeholders are up to date on trial progress, and creating mitigation plans so that when problems do occur the team has a response plan already in place to minimize its effect on results. They also understand how to translate lessons learned to future projects, so that the research environment is in a state of continuous improvement.
All of this formal training and support takes a lot of time and investment, but it means we can tap a deep pool of experienced project leaders to run our clinical endeavors with the confidence that they will be ready to manage whatever challenges arise. That is a big differentiator in an industry where every day’s delay means a patient is not getting the therapies they need.
As trials get more complex, the need for skilled project management staff will only become more important. We give our people the skills and tools to anticipate problems, mitigate risks, and maximize opportunities to improve trial outcomes and proactively address problems before they create delays. That translates to better, faster and more effective trials, and a less stressful more collaborative project environment for everyone involved.