Learn eCORE is pleased to feature this blog on clinical research project management authored by Desiree Underwood-Williams, a well-regarded clinical research professional and a dedicated mentor to others working in this field.  Learn eCORE’s library of soft skills training that are included with all subscriptions has project management courses directly related to the tips for success Desiree describes in this blog.

Clinical research is a complex and challenging field. It necessitates the coordination of various people and resources and must be conducted in compliance with rigorous scientific and regulatory standards. To guarantee the success of clinical trials, a strong project manager is essential.

Over the years, the role of clinical project management has evolved, becoming recognized as a pivotal component in bringing therapies to market. Project managers are required to manage multifunctional global trials, which involves adherence to a wide range of regulations and laws. Consequently, an understanding of the clinical research process, regulatory requirements, and ethical considerations is crucial.

This implies that project managers need to be organized and efficient, capable of managing multiple projects simultaneously, and able to meet deadlines. Moreover, they must have exceptional problem-solving skills, as they are tasked with identifying and managing risks and developing contingency plans for unexpected events.

The complexity of projects and the demand for greater efficiency have prompted an increasing need for project managers to possess a wider set of skills and knowledge, including communication, strategic thinking, and leadership (Myshko, 2008). This trend has become more pronounced in recent years, with a study by Verma et al. (2021) stressing that project managers now require a blend of technical, business, and strategic skills. Thus, developing strong communication and interpersonal skills is crucial, as project managers must liaise with various stakeholders, including scientists, clinicians, regulatory agencies, vendors, and healthcare providers.

Furthermore, project managers need to foster team leadership skills such as delegation, empowerment, active listening, and conflict resolution. This aligns with a recent study by Lu et al. (2020) which stated that providing leadership and cultivating a positive team environment leads to improved project outcomes. This viewpoint is reinforced by PMI’s Project Management Professional exam update in August 2021, in which 42% of the questions are mapped to the “People” domain, emphasizing that PMs “must possess the skills to effectively lead and motivate a project team throughout a project” (Project Management Institute, 2021).

Project managers must also keep pace with evolving technology trends. Technology, particularly digital innovations, has significantly influenced how project managers conduct and monitor trials. A study by Lamberti et al. (2018) underscored how such advancements have become game-changers in improving efficiency and real-time communication in clinical trials.

Here are some tips for becoming a successful Clinical Project Manager:

1. Familiarize yourself with the clinical research process. This includes understanding the different phases of clinical trials, the regulatory requirements, and the ethical considerations involved in clinical research.

2. Develop strong communication and interpersonal skills. Project managers must communicate effectively with a diverse range of stakeholders, including scientists, clinicians, regulatory agencies, patients, and healthcare providers.

3. Stay organized and efficient. Project managers should be adept at managing multiple projects simultaneously and meeting deadlines.

4. Develop strategic thinking and problem-solving skills. Project managers need to identify and manage risks and develop contingency plans in case of unexpected events.

5. Embrace technological advancements. Being comfortable with technology, especially digital innovations, can significantly improve the efficiency and effectiveness of project management in clinical trials.

6. Regularly update your knowledge and skills. The field of clinical research is continually evolving, and staying current is essential for success. This can be achieved through continuous learning and professional development, such as obtaining relevant certifications or attending industry seminars.

In conclusion, the role of clinical project managers has broadened, requiring a balance of various technical, business, and strategic skills. Project managers are instrumental in the successful execution of clinical trials, highlighting their importance in the pharmaceutical industry and clinical research.

Disclaimer: The opinions and views expressed in this article are solely those of the author and do not necessarily reflect the official policy or position of WCG Clinical.

References:

Myshko, D. (2008). The Evolving Role of the Clinical Project Manager. Pharmavoice.

Verma, D., Sinha, N., Singh, A., & Kumar, S. (2021). A Study on Critical Skills of Project Managers in Clinical Research Organizations. Therapeutic Innovation & Regulatory Science.

Lu, Y., Wang, Y., Lu, L., Li, Y., & Liu, Z. (2020). Leadership style and project success in the healthcare industry: The mediating effect of teamwork. Journal of Healthcare Engineering.

Lamberti, M. J., Kubick, W., Awatin, J., McCormick, J., & Carroll, J. (2018). Using Digital Health Technology to Better Generate Evidence and Deliver Evidence-Based Care. Journal of Clinical Pharmacology.

Project Management Institute. (2021). A Guide to the Project Management Body of Knowledge (PMBOK® Guide) – Seventh Edition. Project Management Institute.

About the Author: Desiree Underwood, PMP, CLSSBB is a strategic project leader with over 20 years combined experience in Healthcare, Health Equity, Clinical Research and Clinical Technology.  She is currently the Director of the Project Management Office (Innovation & Integration Office) at WCG Clinical.