How Does the Project Manager Contribute to the Success of Clinical Trials?

Clinical trials are fundamental tenets of the drug development process. Conducting a successful clinical trial hinges on a strong clinical plan and a competent investigator on the one hand, and a dedicated project manager and robust project management on the other. ¹

This article emphasizes the need to retain skilled project managers as a critical aspect in achieving clinical trial success. (1)

Managers’ Role in Achieving Successful Clinical Trials

Effective management is a crucial phenomenon in achieving efficient and quality clinical trial feasibility. Trial managers oversee the planning, execution, and supervision of the project, and ensure its completion within the stipulated timeline and budget. ¹

As the ultimate team leaders, project managers possess the requisite leadership skills to not only motivate the team but also boost productivity. They ensure that the project roles and responsibilities are well understood among the team and align with the overall goal of the trial.

Project managers are proficient in risk mitigation and laying out robust contingency plans for the team. They ensure effective communication among team members regarding the trial specifics and progress.

The Need for Skilled and Experienced Project Managers

A competent project manager turns a robust work plan into a success through strategic implementation. They remain clinically focused on the one hand while seeking to achieve business goals on the other. Ideally, a project manager should possess the following skills:²

• Scientific competence – Project managers should be well-versed with the relevant regulatory guidelines and requisite expertise and competence in overseeing quality clinical trials.
            
• Communication and presentation skills – Competent project managers communicate seamlessly with stakeholders regarding clinical trials, including sponsors, authorities, and the team.
• Project managers are skilled in strategic planning and can adopt a viable approach to conduct an effective clinical trial process.
• Competent project managers possess the requisite skills to not only negotiate but also mediate between various stakeholders in a clinical trial
            
• Financial management skills to oversee the budget appropriation and monitor the project costs
            
• Project managers have the leadership skills to guide, organize and motivate team members

The Essence of Retaining Competent Project Managers

As the industry experiences rapid growth, so is the increasing demand for competent managers. The success of trial projects hinges to a large extent on the input of experienced, competent, and reliable project managers who oversee the entire project management process.

Such managers earn the loyalty of sponsors; thus, increasing repeated business and upholding the organization’s reputation. A project manager links the team and the sponsor, and his change can adversely affect the harmonious working relationship and the ultimate project outcome. A significant amount of time and financial resources are required to change a project manager, particularly during an ongoing project trial. Notably, employee recruitment and orientation may take weeks, while completely integrating the team would be more time-consuming.

Companies may encounter challenges in retaining skilled project managers.³ Attracting and retaining such managers remains a fundamental requirement to achieving competitive advantage. Project managers are indispensable in achieving the desired trial outcome and performance; therefore, companies must address barriers to their retention to remain competitive.

Addressing Employee Retention Dilemma

Turnover has proven costly to companies. High turnover may adversely impact on the relationship between companies and sponsors, leading to business loss.

To overcome the challenge of turnover, organizations embrace myriad initiatives to retain competent managers.

Such initiatives may include;

• Providing a suitable working environment to encourage growth, including availing of learning opportunities and upskilling.
• Motivating project managers by acknowledging and/or acknowledging achievements
• Providing support to the project managers and integrating their concerns and ideas into the management process.
• Upholding job satisfaction by appreciating the efforts of the managers; offering competitive remuneration; and, advocating for work-life balance.

How Dokumeds Retains Project Managers

The company embraces a meticulous recruitment process to ensure the hiring of a competent project manager. Offering careers in clinical research, Dokumeds provides career growth opportunities among project managers. It has a well-established program to oversee, manage, and evaluate the managers’ performance and provide organizational support. To retain the project managers, Dokumeds ensures job satisfaction through multiple approaches, including fostering open communication between managers and team members. Such initiatives justify the company’s low staff turnover rate below the industry as reported in 2020.

References

1. Mitchell E, Goodman K, Hartley S, et al. Where do we go from here? – Opportunities and barriers to the career development of trial managers: a survey of UK-based trial management professionals. Trials. 2020;21(1):384.
2. Farrell B, Kenyon S, Shakur H. Managing clinical trials. Trials. 2010;11:78. Retaining project managers–an empirical analysis of the antecedents to project manager’s satisfaction and intention to quit. Available at: https://www.pmi.org/learning/library/retaining-project-managers-an-analysis-satisfaction-8943#:~:text=Hence%2C%20retaining%20project%20managers%20becomes,%2C%20%26%20Allen%2C%202007. Accessed on: 06 April 2021.

Author of the article:  Janis Brix, CEO Wigwam