Clinical trials are one of the most critical steps in the entire drug development process. Apart from a strong clinical trial plan and a competent investigator, conducting successful clinical trial warrants robust project management and a dedicated project manager.\(^1\)
This article covers the role of project managers in achieving clinical trial success. We also discuss the importance of retaining skilled and experienced project managers.
Project managers play a vital role in effective trial management and delivery of high-quality research results. They ensure that each trial is planned, implemented, and supervised efficiently, and the project outcome is achieved within the agreed timelines and budget.\(^1\)
Project managers are the ultimate team leaders. Their leadership skills are important to boost the team’s morale and productivity. The project managers make sure that the team understands their roles and responsibilities well and work towards a common goal of achieving trial success. They ensure that the team has robust contingency plans and is adept at managing risks across several projects. Managers see that there is effective communication among the team members regarding the trial specifics and progress.
A robust work plan will not ensure project success unless implemented strategically by a strong project manager.
The project managers' skills should strike a balance between being clinically focused and being business-oriented. Ideally, a project manager should possess the following skills:\(^2\)
Swiftly growing industry needs have increased the demand for competent project managers. Reliable, experienced, and responsible project managers, who are involved in the trial project from the trial initiation to the end, understand the project and the sponsor requirement well.
Reliable project manager positively impacts sponsor's loyalty, which increases repeated business as well as the reputation of the organization. The project manager acts as a bridge between the sponsor and the team. A change of project manager can significantly impact a well-established working relationship, which may ultimately affect the trial outcome.
Change of project manager during an ongoing trial requires a significant amount of time and financial resources. Initial onboarding may take several weeks, whereas complete transfer and adaptation may take longer.
Retention of project managers might be a challenging task.\(^3\) Companies must be able to retain and attract skilled project managers to maintain a competitive advantage. Though a certain degree of turnover is unavoidable, solving the talent retention challenge is critical as project managers are indispensable to achieve trial outcome and sustain high performance.
Solving the talent retention challenge
Turnover can be a costly affair for companies. High turnover may weaken the relationship with a sponsor and lead to business loss.
Companies can take the following steps to retain project managers:
In 2020, Dokumeds' project staff turnover rate was significantly below the industry average. When recruiting prospective project managers, the individual's compliance with clinical trial requirements and personal characteristics to ensure long-term association are meticulously evaluated. Dokumeds provides its project managers a long-term career perspective and allows them to grow within the company from the very beginning. There are several success stories where an employee who joined as a Clinical Trial Assistant has learned, developed, and was ultimately promoted to a project manager.
Dokumeds always tend to involve project managers in more complex studies as they develop their project management skills so that they get to learn and grow with these challenging projects.
A well-established project manager oversight procedure to continuously plan, manage and evaluate the manager’s performance and ensure organizational support to project managers is developed and implemented.
Job satisfaction is an important aspect to retain project managers. Open communication between colleagues, line managers, and senior management is encouraged to avoid any potential issues. Suggestions from project managers to improve operations and other processes are always encouraged and taken into account.