Conducting Clinical Research trials is a complex and costly task. It involves a large amount of money, many people, and a lengthy amount of time. The purpose of Clinical Trials could vary from project to project. For example, a Clinical Trial is being done to investigate the efficacy of new drugs or treatments, efficiency and consistency of a new medical device or methodology, or further exploration of a certain medical condition to expand the understanding behind it.
Running a Clinical Project is undeniably complicated. The success, or failure, of a Clinical Trial is also determined by how well it is being managed. Clinical Trials require lots of processes and people working on an organized structure to meet certain goals in accordance with a schedule and budget. So, Project Management techniques and methodologies should be implemented to control and supervise the entirety of the operations.
According to a published article entitled “Researchers’ Experience with Project Management in Health and Medical Research: Results From a Post-Project Review” (Payne, France, Henley, D’Antoine, Bartu, Elliot, & Bower, 2011), Project Management is defined as the application of skills, tools, techniques to a broad range of activities in order to meet requirements of a particular project. Furthermore, in the same article (Payne et al., 2011), states that, a life cycle of a project contains 5 processes and 9 knowledge areas about management. These guidelines, as explained in the aforementioned article, came from the book “Project Management Institute: A guide to project management body of knowledge: PMBOK guide (Newtown Square: Project Management Institute, 2004).”
Processes and Knowledge Areas
According to PMBOK (2004), the 5 process groups in a project are initiating, planning, executing, controlling and monitoring, and closing. On the other hand, the 9 knowledge areas about management are integration, scope, time, cost, quality, resources, communication, risk, and procurement. Based on the aforementioned considerations, Project Management is obviously a key to increase productivity, efficiency, harmony, professionalism, and chances of success in a Clinical Trial. It can bring clarity and direction as to where the project should be heading, what roles do certain staff do, what are the current expectations and conflicts the project is facing, and what aspect of the project should be improved. Also, Project Management can make a difference in terms of keeping all the procedures and processes timely and on track.
Tasks of a Clinical Project Manager
According to the article published in 2008 by Denish Myshki entitled “The Evolving Role of the Clinical Project Manager”, studies are more complicated. It is more “multinational” than ever. The laws and regulations are evolving as well. Myshki (2008) also added that, “the roles that a Project Manager should do is broadening because of a need for efficiency in clinical development, the multinational scope of development, and new technologies that allow for faster communications.”
There are a lot of positive impacts and benefits that a Clinical Trial could receive from the implementation of Project Management. But these advantages come with a tantamount number of responsibilities that a Clinical Project Manager should face, especially nowadays where the medical ecosystem is changing rapidly in terms of complexities of laws and technological advancements.
According to an article published in 2019 by Mike Wood entitled “What does a Clinical Project Manager Do?”, the tasks of a Clinical Project Manager are, but not limited to:
Preservation of records that are required for the study. For example, study oversight, risks management, patient safety and ICH-GCP compliance.
- Overseeing process to ensure compliance with protocol and policies.
- Supervise subject enrollment and making sure consent is properly communicated and obtained.
- Assessment of qualification of potential subjects through MR, Interviews, and other methods of screening.
- Record events and data and confer with PIs about unfavorable events.
- Participation in QA audits
- Conflict resolution
- Preparation of documents related to the studies such as IRB documents, progress reports, protocol worksheets, manuals, and so on.
- Documentation of dropout subject information
- Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.
- Code, evaluate, or interpret collected study data.
- Participation in research budgets and monetary disbursements.
- Participation in the development of study protocols.
- Instruction of staff in the procedural and scientific aspects of the study being conducted.
- Communicate with laboratories or investigators regarding laboratory findings.
- Review scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues.
- Management of drugs supply or devices necessary for study completion.
Skills of a Clinical Project Manager
CPMs (Clinical Project Managers) are expected to have a variety of experience and technical skills. Since CPMs are taking leadership roles, they must possess outstanding, if not excellent, mastery in comprehensive analytics, data management, clinical monitoring, medical writing, quality assurance, and other “hard skills” that are needed depending on the demand of the study.
According to an article published by Lizzie Evans in 2016 entitled “Do You Have the Skills To Be A Clinical Project Manager? “A clinical research project team typically comprises team members with a wide-ranging variety of experience and technical skills across clinical research functions such as clinical monitoring, data management, biostatistics, medical monitoring, medical writing and quality assurance.” Furthermore, Evans (2016) added, “being technically skilled is important in order to achieve project goals and targets, but it requires a Clinical Project Manager with strong soft skills for a team to truly be successful.”
Even though CPMs are expected to be well-versed in the medical field, they are still dealing and working with people. While hard skills are essential for requirements, “soft skills” are also determinants of a Clinical Trial’s success. Based on the same article mentioned above, these are some soft skills that are essential to a Clinical Trial:
CPMs are expected to be knowledgeable or experienced in every field needed in the clinical Trial. CPMs should always know who is responsible for what. CPMs should also understand how the processes work for each function.
In a Clinical Trial, there are a lot of processes being done simultaneously. All of the processes have different goals, timelines, and requirements. To be able to manage and supervise the sequence of events seamlessly is one skill that a CPM should possess.
CPMs are expected to know the difference between micromanagement and assistance.
CPMs are also expected to be understanding, collaborative, and setting realistic but achievable goals and expectations. They must see to it that everyone is on board and on the same page.
CPMs are expected to communicate constructively. Discuss conflicts and achievements openly and willing to take suggestions or opinions from colleagues.
Conducting and Managing a Clinical Trial is surely a complex task to do. It requires a great amount of effort and expertise to be able to contribute to the success of the study. Therefore, working with experts in Clinical Research field like Project Managers can surely give you optimal results and less trial and error on your side.
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