Seek hard and soft skills in the ideal trial manager
Putting the right person in charge of a clinical trial can mean the difference between a highly productive trial and a waste of time, money and resources. Yet finding the correct person can be a tall order, since the role calls for both analytical and emotional intelligence.
The study manager must be able to control crucial elements ranging from the design of a valid test to effective administration, recruiting, logistics and follow-up. Concurrently, he or she must be a skilled communicator capable of making participants feel engaged and motivated to continue.
From a financial standpoint, the impact of hiring the wrong leader can be huge. A recent study finds that poor project performance is often responsible for a 12 percent loss from every $1 billion business project; a similar pattern could result in $30 million wasted for every $250 million spent on drug development.
Focusing on better project management can make a huge difference in such outcomes, the study reports; 71 percent of organizations that do so meet their original goals and business intent, compared to 52 percent of those who do not.
“One of the major obstacles in Phase III clinical trials still appears to be missing effective leadership at the project level,” notes Marylyn Donahue in AppliedClinicalTrialsOnline. “Interestingly, long-term experience in clinical research and overall knowledge of drug development appear … to be less important for a project leader as compared to other knowledge, behavior and skills.”
What are some of those desirable skills? Consider how the following traits could help your next trial leader achieve better success.
Strong communication skills. In a recent survey of clinical research professionals, effective communication was ranked by 44 percent of respondents as the No. 1 most important ability in a leader. The best manager forms a communication strategy before recruitment even begins, keeping stakeholders well informed of the study’s intent, logistics and progress.
Empathy. A study leader who seems to focus more on data and results than human beings will not be highly regarded by participants who are giving up their time and going out of their way to be part of a study. Trial participants are often already dealing with the unpleasant effects of illnesses and already feeling vulnerable; a savvy manager finds ways to make them feel listened to, appreciated and safe throughout the study process. “Unlike sympathy, which is defined as feeling sorry for another person, clinical empathy is the ability to stand in a patient’s shoes and to convey an understanding of the patient’s situation as well as the desire to help,” explains Julia Wick on LongReads.com.
Ability to set and meet goals. In the same survey, clear goal setting was identified as most important by 34 percent of respondents. An effective leader must be clear on exactly what the team is trying to accomplish from both a scientific and a budgetary standpoint, demonstrating a clear plan for achieving valid results that incorporates priorities, benchmarks, contingency plans plus roles and expectations for all team members.
Experience. This was ranked most important by 7 percent of survey respondents. Many candidates may offer stellar organizational skills, but the ideal manager will have already experienced the challenges of an actual trial, so he’s well familiar with possible pitfalls and how to address them. Understanding realistic timelines and knowing firsthand what’s going to happen at each stage allows him to be proactive, reducing the risk of delays, added expenses or other major issues.
Clinical and scientific acumen. An effective leader must be strong and up-to-date in scientific study design, research processes, subject safety, data management and analysis, regulation and compliance, ensuring that no data is skewed or wasted and that no participant is put at unanticipated medical risk over the course of the study.
Administrative ability. Highly skilled managers are able to maintain clear records of all aspects of the study, remaining organized, managing everyone’s time effectively, ensuring compensation is in place, following through on what they say they’re going to do and aiming for maximum transparency.
In short, finding a trial manager with the right resume and skill set could go a long way toward making your next trial a success.
“A well-structured protocol for a clinical trial may be able to answer clinical questions, but it cannot be deemed enough to ensure success in the face of incompetent management of time as well as human and economic resources,” reads a recent report filed with the National Center for Biotechnology Information. “The requirements of a clinical project manager are similar to those of any other project manager … but also add to these scientific competence and motivation.”