What Does a Clinical Trial Project Manager Do?

Clinical trial project managers keep research studies running on time and on budget, while keeping each piece compliant, too. From choosing vendors, to overseeing budgets, to reporting on results, every day tends to be busy and varied for a project manager.

Not all clinical trial projects have an official project manager with that title. But if you manage several parts of a clinical trial at a site, you’re acting as project manager, even if you have a different title.

Responsibilities vary from site to site, but a clinical trial project management role tends to include these critical pieces:

Choosing vendors. As project manager, you may be tasked with choosing vendors for clinical trial technology, such is IWRS and electronic patient-reported outcome (ePRO) technology. You may also review clinical trial recruitment companies if you’ll be working with them for help enrolling patients. For help choosing vendors, create a spreadsheet or document with certain questions for each, so you can compare your options.

Overseeing study timelines and budgets. As project manager, chances are you'll be in charge of making sure the team sticks to a study timeline and stays on budget throughout the trial. This part of the job requires a lot of communication with key stakeholders for each part of the trial. To stay organized, make sure you have a main point person you communicate with for different pieces of your project, who can then pass information along to others who need it.

When considering stakeholders for each piece of your project, project management experts recommend listing out points of contact for three different roles:

  • Responsible: This is your main point person, with whom you will communicate most for this part of the project. This is also the person who will be completing the necessary tasks.
  • Accountable: The manager or reviewer for the person responsible. They may want to be included in communications as well, though it's not necessary.
  • Consulted: Others whom the person responsible involves in the completion of their piece. It's helpful for the project manager to be aware of the roles they play, but they don't need to be included in updates about the project.

Submitting materials to the IRB. Part of your job as project manager may be to submit trial materials, including outreach materials, to your study's Institutional Review Board (IRB). Every IRB is different, so the best way to approach materials submission is to look at a document that was approved by the IRB before as a template. If that's not available, check out resources that research universities have compiled to help with the submission process. The University of Southern California has a useful library of guides and checklist to help you prepare materials for submission.

Creating reports. Another important role of a clinical trial project manager is to create reports tracking the progress of your trial. Before the trial starts, ask stakeholders about what reports they need for each part of the trial. Using technology to automate reports on patient enrollment, for example, can help save time, but chances are your team will still require some analysis of the data you're sharing. As part of reporting, you may also plan and lead meetings with key stakeholders to discuss progress and roadblocks throughout the trial. At a site, you may also host meetings with the trial sponsor to share updates and feedback, as well.

If you're looking for help with the recruitment piece of a clinical trial, download our case studies to see how Antidote can help. We work with 250+ health nonprofits and patient advocates to connect interested patients with research.