The process to design, develop, and launch a new drug is a lengthy one – and much of the final success rides on the clinical trial stage. To organize a successful clinical trial that meets all scientific and regulatory requirements, biomedical companies need to recruit a multidisciplinary team. This must involve competent investigators, a tightly-knitted team of assistants, efficient clinicians, and thorough administrative support.
So how does such a diverse team manage to work harmoniously towards a common goal? Commonly, the project manager is the one who makes this happen. Here, we will learn more about the effect a project manager can have on a clinical trial, as well as strategies to find, recruit, and retain the best project managers.
Why Project Managers are Critical for Successful Clinical Trials
Part coordinators and part supervisors, project managers are responsible for ensuring a clinical trial is completed successfully and provides conclusive results.
Project management is a highly flexible discipline, as it may encompass:
- Leadership ability and team building
- Assigning budget allocations and expenses
- Allocating roles and responsibilities across the team
- Establishing operating procedures and communication channels across team members
- Identifying risks and vulnerabilities, and preparing appropriate contingency plans
The wide set of tasks that fall under their purview provide them with a lot of independence in their day-to-day tasks. However, project managers are also a visible “face” behind the success or failure of any task.
Finding and Recruiting Good Project Managers for Clinical Trials
At first glance, the responsibilities of a project manager seem to correlate with the typical curriculum of any business-oriented educational program. Yet, project managers are usually highly specialized professionals, as they often need to have hands-on prior knowledge of an industry before overseeing a project.
For clinical trials, this poses a significant challenge: beyond the organizational skills and leadership talent that any project manager should have, the ideal candidate should also have specific scientific competencies, such as familiarity with the concepts of clinical research and the regulations behind protocol design and approvals.
Recruiting vs in-house training: Which chance is your company willing to take?
This combination of business-oriented and clinical knowledge is becoming increasingly hard to find. Ultimately, most companies often choose to recruit project managers who have already led trials to completion for other competitors. Nurturing a novel project manager who has no prior experience in clinical research will require additional industry or product-specific training.
As an alternative, other companies offer their clinical research associates, or other investigational staff, the opportunity to train as project coordinators and deputy managers. Either way, some degree of investment will be necessary to find a competent and experienced project manager.
Retaining Outstanding Project Managers: An Ongoing Battle
The field of biopharmaceutical research has become increasingly competitive over the past couple of decades. In turn, this has increased the degree of competition for experienced and reliable project managers who have a proven track record of getting investigational medicinal products approved.
For Clinical Research Organizations, the task of retaining their best project managers is now of vital importance. Often, past trial Sponsors who had a good relationship with a specific manager can seek for the manager specifically, and consequently, follow them across different companies. In their position as the middlemen between the research team and the sponsors, project managers can inspire a great degree of loyalty.
Because of this, companies who have managed to recruit an outstanding manager must often place extra effort to retain them – especially while the trial is still ongoing. This effort is shaped by two forces:
- First, the unavoidable fact that the biomedical research industry is amidst a “war for talent”, where generous offers for unusual talent abound.
- Second, that changing managers in the middle of a trial can have deep consequences. The process to recruit and onboard a new one, amidst an ongoing challenge, will be expensive and can cause dissatisfaction in the team or missed deadlines.
Strategies to Retain Exceptional Talent
It is impossible to avoid the departure of a small number of employees in any industry. However, a long-standing partnership between a project manager and a specific clinical research organization or sponsor can yield ever-more efficient processes and successful outcomes.
Some of the strategies that can help achieve this include:
- Offer competitive pay and bonuses for high achievement
- Provide frequent opportunities for career advancement
- Ensure the managers are aware of the available programs for further education, and how the company can help access them.
- Keep clear and transparent communication channels, featuring frank discussions about career prospects
- Acknowledge and celebrate special achievements
- Provide an empathetic attitude to their managers’ questions and work-life balance
In many ways, these efforts can be summed as providing project managers with access to continuous growth and ensuring they are aware of it.
Talent recruitment efforts are often expensive and full of grand promises. However, long-term success often depends more on talent retention. Project managers with experience in clinical trials are a rare resource, so companies need to listen to their suggestions and ensure they remain satisfied with their jobs.