7 clinical trial project management courses to consider
Effective clinical trial project management is vital for keeping studies on time and on budget., and project management skills are key to doing this successfully. While many project management skills can be learned on the job, clinical research project managers may find formal training programs to be highly beneficial.
Below is a list of project management courses that can help project managers get the training they need. Many of the courses are conducted online, or are hybrid programs with both online classes and in-person workshops.
Courses for clinical trial management training
- Project Management for Clinical Research Professionals - ACRP
This course, available to organizations, provides training on the specific project management skills needed by study sponsors and CROs. Over the two-day course, enrollees will learn about how to take control of projects, improve timeline design, enhance documentation, and optimize overall trial management.
- Certificate in Pharmaceuticals and Clinical Trials Management - Rutgers University (Online)
This year-long certificate program is designed for bioscience and pharmaceutical professionals, in addition to engineering and science graduate students. It incorporates classes about drug development and discovery alongside ones that focus on business, marketing, and project management.
- Drug Development and Lifecycle Management eLearning Program - DIA
DIA is a global organization for life science professionals that provides certifications to project managers in the clinical research field. Courses cover general management, conflict management, budgeting, drug development, and adverse event reporting. Additionally, this program offers a group rate for companies interested in purchasing the program for more than 10 users.
- Project Management Certificate Program - The Pharmaceutical Education & Research Institute
The Pharmaceutical Education & Research Institute offers this certificate program designed for clinical research professionals interested in exploring project management. It offers courses in drug development, project management in the research-based pharmaceutical industry, statistical concepts used in clinical trials, and other relevant classes.
- Project Management Professional Certification - The Project Management Institute
While this certification is not specifically designed for the medical research industry, the Project Management Institute is highly regarded in professional circles. Attendees can apply the skills they learn to clinical trial management, as the courses cover many relevant topics such as project scope, resource management, and communication skills.
- Postgraduate Certificate in Clinical Trial Management - Parexel
This program is designed for working professionals who have graduated from the life sciences field (nursing, medicine, and other life sciences) who are interested in pursuing a career in clinical research. It is a six-month course made up of online modules and in-person weekend sessions with the Paraxel team in Berlin, Germany. Courses cover topics such as drug development, regulatory affairs, clinical data management, project management, and more.
- 30-Hour Clinical Project Management Fundamentals Certification Program - Barnett International
This online course is designed for anyone looking to gain experience in clinical research project management, whether they have an established career in project management or not. It includes guidance on developing clinical trial project plans, budgeting considerations, trial closure processes, and more.
Clinical trial project management tips for success
When coordinating the details of a clinical trial, there are a few tips that can be helpful in keeping the project on track.
- Start with a project plan. Creating a project plan should be the first step before any new trial launches. This plan will establish a timeline for key milestones, outline which staff members are responsible for each element of the study, provide communication details, and include a risk assessment that addresses potential roadblocks.
- Create a plan for potential risks. While the ideal would be to avoid any delays throughout the trial, it is better to be realistic and create a risk assessment plan. Common challenges include delays with IRB approval, staff turnover, patient recruitment and protocol changes. While this can feel like a lot to consider, planning for it in advance can ensure that challenges can be addressed more efficiently in the moment.
- Create a plan for stakeholders. To ensure the study gets buy-in from the right stakeholders, it’s important to include them in the planning process. By using the RACI method of project management, each part of the plan will note who needs to be involved and in what capacity. The RACI method keeps track of who is:
Responsible. This is the person who does the actual work of the task (for example, a marketing lead who gathers outreach material to submit to the IRB).
Accountable. This is the person who ensures the work is done thoroughly, accurately, and on time.
Consulted. This includes any additional people who may need to weigh in on a piece of the project, such as supporting team members or subject matter experts
Informed. The individuals who are kept up-to-date on the progress of the project, but don't need to give approval.
- Schedule time to think. There are many moving pieces involved with running a trial, so it is important to schedule time for thinking and reflection to ensure everything is operating according to plan. This time can be used for anything that’s necessary for continued success, such as establishing project scope, refining objectives, defining courses of action, and analyzing metrics.
- Monitor and analyze your results. Throughout the project, continually monitor results and watch out for inefficiencies that arise early on. Additionally, after the trial is completed, it is important to take time to review the experience before moving on to the next project. This is a good time to solicit feedback from key stakeholders and open the floor for suggestions on how to improve processes for future trials.
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