Project Management Frameworks

Project Management Framework and Tools in Clinical Trials

Project management’s maturity as a discipline has had wide-reaching effects across most industries.

It’s changed the way people manufacture products, develop software, plan company strategies — and even how clinical trials are conducted.


Here, we explore how the evolution of project management has impacted clinical research, and what aspects of project management trial leaders need to know to be successful.

Meet Your Clinical Project Manager

Because clinical trials have so many stakeholders and moving parts, it makes sense that someone should take responsibility at a project level.

As Genesis Research Services Business and Clinical Research Manager Dom Bailey points out, this person — the clinical project manager — is responsible for explicitly laying out the project objectives, scope and stakeholder management plan.

Additionally, the project manager will work with a CRO’s leadership team to ensure things like sufficient recruitment numbers and that the necessary project management tools are in place.

Dalfoni Banerjee at 3Sixty Pharma Solutions says a good clinical project manager must be able to plan and establish key metrics, communicate very well, and remain oriented on the project’s goals while maintaining flexibility to accommodate any unexpected changes.

For trial leaders, perhaps the most important trait in a project manager is their communication skills. “Nothing is worse than working for an out-of-touch project manager—someone who is lost in the project plan or the study metrics, or making assignments without listening or making any kinds of assessments or mid-course corrections,” Jim Moat at IMARC Research writes.

“Someone with a balanced view of the big picture and the smaller, but important, details, is bound to lead a more successful project and team.”

Moat underscores how important relationships are in managing a trial, which means a good PM knows how to listen and is willing to spend time with research staff to understand realities on the ground.

Zain Asad, M.D., and Kat Niewiadomska, Ph.D., write for the American College of Cardiology that their own experience with project management made them better team members. The PM perspective allowed them to see how each person complemented others and fit into a cohesive team.


The Rising Influence of Agile Project Management in Clinical Trials

Nearly 20 years ago, the Agile Manifesto laid out a new framework for developing software by making the production process iterative and dynamic.

Today, that methodology has found purchase across industries, and its principles are nudging clinical project management into new directions.

Most clinical project managers apply agile frameworks in an effort to cut costs and improve efficiencies. That said, aspects of agile such as iterative development and regular opportunities for stakeholder feedback create other opportunities in clinical trials.

As Syneos Health notes, an agile approach to clinical trial management can:

  • Break up siloed teams and facilitate cross-functional cooperation.
  • Upend linear business processes and replace those with opportunities to innovate.
  • Center stakeholder needs.
  • Facilitate “early and proactive dialogue with regulators to support expedited pathways for bringing new products or innovation to market.”

As promising as that all sounds, though, agile’s uptake has been stifled on a few fronts. In a 2018 dissertation for Harrisburg University of Science and Technology, Jitendrakumar Narola surveyed nearly two dozen healthcare IT professionals about their experience with agile projects in clinical trials.

Narola’s research found that many respondents were hesitant to embrace an agile approach to project management because they didn’t feel sufficiently familiar with the framework, or because they weren’t sure how compatible it would be with FDA regulations.

Further, agile transformations are more fundamental undertakings than simply tweaking how a project is managed. “[A]gile methodology is not applicable neither to all parts of a study nor to all kinds of studies, but striving for an agile transformation in an organization as a whole will pave the way in making clinical trials as ‘adaptive’ as possible,” researchers Katarina B. Pavlović, Ivana Berić and Ljiljana Berezljev write in the European Project Management Journal.

This, of course, speaks to a larger movement among researchers who lean on adaptive trial designs to make data collection and analysis concurrent during an in-progress trial.


The Tools Shaping Clinical Project Management

The fundamental tasks of project management are the same, no matter the industry or the project.

A clinical project manager will specifically need a tool to help with:

  • Creating the work breakdown structure.
  • Analyzing and mitigating risks.
  • Planning budgets.
  • Determining milestones and key metrics to track.

This is the kind of work that can be done in a clinical trial management system (CTMS). A CTMS should give you space to organize an electronic trial master file (eTMF), which is absolutely crucial in what Jim Moat at IMARC describes as “telling the story of your study.”

“Ensure your trial master file is kept current and complete,” he writes. “ … Make judicious use of notes-to-file and memos to document unusual steps taken in a given situation. As we say at IMARC, ‘you’ve done the work; now write it down to take credit for your work.’”

Further, ensure your CTMS allows you to share documents (or at least integrate with a tool like Microsoft SharePoint, which facilitates document collaboration), and that it provides a place to track timelines and milestones.

From there, a project manager might opt for a separate project management platform that accommodates their preferred methodology. For example, a tool like Asana or Microsoft Project Manager can help visualize timelines, budgets and tasks.

Or, if the project manager needs to organize work in a Kanban-style workflow, tools like Trello or MeisterTask can help visualize those tasks.

Finally, a project manager needs to be able to host and lead meetings, sometimes with remote staff. In such cases, a conferencing tool like Zoom or GoToMeeting would be useful.

With the tools above and a framework in place, a clinical project manager has what they need to try to steer a clinical trial toward its goals within budget and within expected timelines. Of course, no projects go exactly as planned, so transparency and communication go a long way to getting a trial back on track in the face of unexpected changes.

For clinical trial leaders, having this kind of perspective into the project-management aspects of a trial will be useful in marshalling resources and leading teams as needed.

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