What exactly is clinical project management?
Any multi-step process requires discipline, coordination, and structure. Performing a clinical trial is, of course, comparable. There are frequently many moving pieces, and competent clinical project management is required to ensure the trial’s success. Among these moving pieces include defining a plan, communicating changes, and calculating risk.
According to the Project Management Institute (PMI), clinical project management is the “application of knowledge, skills, tools, and techniques to project activities in order to meet project requirements.” It requires understanding of scope, time, money, quality, risk management, communications, and stakeholder management, among other things.
To help you understand project management better, it may be broken down into five basic steps:
- The initial stages in designing an idea are to examine the project’s requirement and identify the main decision-makers.
- Making a plan requires outlining the work to be done, as well as the resources to be assigned, the budget, and the timeframe.
- Task distribution entails informing each team of what is expected of them and when they must do it.
- Project tracking entails comparing the project’s current condition and progress to the original plan and making appropriate modifications.
- stressing project accomplishments and lessons learnt for the future.
When it comes to ensuring that clinical trials are set up, recruited for, carried out, and reported on time and under budget, project management is critical. This article will discuss the role of the clinical trial project manager, as well as tips on developing project plans, involving stakeholders, interacting with them, submitting them to the IRB, and reviewing them.
What does a project manager do?
Although the responsibilities of a clinical trial project manager differ from site to site, they often include the following components, each of which is critical to the study’s success:
Choosing a vendor: Running a clinical trial requires more than just the research team. Expertise in areas such as clinical trial patient recruitment, electronic patient-reported outcome (ePRO), and IWRS technology is often provided by third-party suppliers. The project manager may be tasked with verifying these suppliers and assisting with comparisons of options.
Timeline and financial management: Each research has an initial budget and timeline, yet more than 80% of clinical trials run late and over budget. When research is halted, patients are left waiting for answers. In this case, a project manager may utilise their experience to manage expectations in the event of modifications to the timeline or budget, as well as hold the trial team accountable for the time and money spent on the trial. This requires regular connection with key stakeholders as well as the ability to motivate others.
IRB submissions: All research materials, including outreach materials, must be approved by the Institutional Review Board (IRB). The clinical trial project manager may be in charge of acquiring and submitting paperwork from suppliers and stakeholders as required. Because each IRB is different, the project manager will need to check previous submissions as well as any available submission templates to ensure that the study’s individual IRB guidelines are met.
As part of monitoring trial progress and meeting deadlines and budgets, clinical trial project managers may be entrusted with preparing and distributing reports on various aspects of study progress. At the start of the trial, discussions with key stakeholders should be conducted to determine the topic matter and frequency of these reports. Project managers may leverage previously existing technology to automate reporting on topics like patient registration or reasons for ineligibility to free up more time for data analysis.
Organising meetings: The trial’s key stakeholders will need to meet on occasion to discuss the trial’s progress and any impediments. To ensure that every detail is covered, the project manager will most likely be in charge of scheduling and supervising these meetings. If the project manager is on-site, these meetings may also include the trial sponsor, who will be looking for updates and comments.
As you can see, the project manager has a wide range of tasks. Despite a vast and diverse profession, there are ways to streamline processes and obligations to ensure that the work gets done. We’ll next go through some clinical project management best practises.
