Culture of clinical trial management

KEARNEY, Neb.—SCORR Marketing, a global marketing and communications firm, teamed up with Applied Clinical Trials—a peer-reviewed resource for professionals that design, initiate, conduct and monitor global clinical trials—to conduct a survey of clinical trial project managers. The objective of the study, which was published in the April/May issue of Applied Clinical Trials, was to gain a better understanding of the level of company support clinical trial managers need and receive, the culture of their organizations and the biggest challenges they face in their jobs.

According to Cliff Echols, market intelligence director at SCORR, “As the complexity of clinical trials increases, the demand for more proficient project managers increases as well. The goal of this survey was to gain insight into the expectations and responsibilities of project managers that have been added as a result of the evolving nature of clinical trials.”

Lisa Henderson, editor-in-chief at Applied Clinical Trials, added, “Sponsors can use the results of this survey to make more insightful decisions and build stronger relationships with project management teams.”

Survey respondents included program managers with varying levels of experience from international pharmaceutical companies, contract research organizations (CROs), academic institutions, biotech companies and research sites. The survey gathered information on current and desired levels of company support and training, various aspects of company culture, availability and importance of career development opportunities, hottest clinical trial topics and trends, responsibilities and working relationships that are the most challenging and skill sets most important for project managers to possess.

Respondents said that training specific to the assignment and training specific to the therapeutic area under study are the most valuable. Project managers felt that the level of training they actually receive is lacking. The training levels that project managers receive that best align with their desires is on-the-job training.

Respondents in CROs are almost twice as likely to identify planning as one of the most demanding responsibilities as are those who work for pharmaceutical companies. Those with less project management experience are twice as likely to note accountability as especially challenging as are more experienced project managers. CRO respondents are five times as likely to identify relationships with information technology personnel as especially difficult, as are pharmaceutical company respondents. Those with company headquarters in the U.S. were more than three times as likely to identify relationships with supply chain personnel as potentially problematic, as were those with company headquarters outside the United States.

Risk management is the topic in which project managers most urgently want news and information. Those with less experience see a greater need for news on current technology use, data quality, future technology use and good clinical practices. Almost two-thirds of respondents believe that, in the past two years, it has become more difficult to obtain competent employees. Respondents said that the most important skill sets for a project manager to possess are good communication skills and a proactive working style. It is important to require specific qualifications for project managers, they added. They also believe that having previous experience working in operations helps them as project managers.

Project managers value opportunities to grow their knowledge base more than opportunities to travel, to be cross-trained or even to advance their careers. After personal growth opportunities, respondents said the most important development opportunities are those that allow them to progress in their careers.

When asked to name the most difficult working relationships, project managers selected relationships with CRAs and third-party vendors most often. Relationships with data managers and supply chain personnel were identified least often.

Respondents said that the most important skill sets for a project manager to possess are good communication skills and a proactive working style, and that requiring specific qualifications for project managers is important to get the job and perform the job. In addition, respondents overwhelmingly believe that previous experience in operations helps them as project managers.