Yakov Datsenko, MD

Clinical development programs in the biopharmaceutical industry have become increasingly complex and continue to do so. In view of strong competition for productive sites; cost and time constraints; challenging internal and external environments; and large multinational stakeholder teams, the skill set of a clinical project leader is nowadays a key success factor. Executive clinical project leaders are involved in development programs encompassing a range of highly complex clinical trials. The key operational challenge of these programs are Phase III clinical trials involving hundreds of investigational sites and thousands of patients across different regions, cultures, healthcare systems, and regulatory environments. How can it be ensured that all contributors to the clinical trial production chain work properly on time, within expected scope, and on budget? One of the major obstacles still appears to be missing effective leadership at the project level.

What are the three most important interpersonal characteristics (soft skills) of a successful/ideal project leader? The authors addressed this question to the clinical research professionals attending the regional chapter meetings, organized by the German Society of Pharmaceutical Medicine (DGPharMed) in Mannheim, Hamburg, and Berlin between February and September 2011. The survey results are presented and discussed in this article.

	The survey was conducted among the clinical research professionals who attended the regional DGPharMed workshops entitled Project Management in Clinical Research held in Germany in 2011. The attendees heard about the principles of project management as applied to the conduct of clinical trials. The vast majority of participants then took part in the survey and selected the three most important characteristics of a successful/ideal project leader and rated these characteristics as most, second, and third most important. The meaning of the term project leader was explained to the respondents as a clinical project manager, study manager, or similarly named function with the responsibility to manage and primarily lead the clinical trial, project, or program depending on the size of the organization and the applicable settings. A skill set differentiation between clinical project leadership and clinical project management was not conveyed.

	The multiple-choice questionnaire offered the following pre-defined characteristics without further definition of terms: long-term experience in clinical research, risk awareness, medical expertise, knowledge of drug development, innovative, confidence-building, dependability, effective communication, clear goals, and proactive working style. The authors pre-selected these characteristics based on results of a Drug Information Association (DIA) tutorial attended by Schenk-prior to the DIA Conference entitled The Future of Pharmaceutical Project Management, Weston, Florida, November 13-14, 2007-where the participants (N=15) identified the three most important personal characteristics of an ideal project leader without any pre-defined answers.

	In the 2011 survey, a free text option allowed for the addition of further characteristics. To rule out any influence by the order of pre-defined answers, the last workshop (23% of participants) utilized the questionnaires with a changed sequence of the characteristics displayed in the questionnaire forms. The order of options on that finally used form was selected on a random basis.

	A total of 226 out of 235 clinical research professionals attending the workshops participated in this survey. Fifty-nine (26%) respondents represented pharmaceutical companies (mid-size to global pharma), 124 (55%) were from CROs, and 43 respondents (19%) worked in other organizations including biotech and medical institutions, or were freelance professionals.

	As illustrated in Figure 1 the majority of participants worked in project or study management (122; 54%), followed by trial monitoring (28; 12%). Clinical research and development functions (both non-medical and medical) were underrepresented in this survey (5% and 7% respectively). Twelve percent of respondents worked in trial monitoring or trial assistance functions. Only 2% of all participants had a data management role. Forty-four (20%) participants worked in other functions not listed above including freelance professionals, investigational sites, or SMO personnel and other functions. The distribution of participants by function and organizational affiliation was similar across all three regional workshops.

	The majority of project and study managers worked in CROs (20% and 13% of all respondents, respectively). Pharmaceutical companies were represented mostly by the study management functions (10% of all participants).

	The overall results of the survey are displayed in Figure 2. They demonstrate that 44% of participants rated effective communication as the most important characteristic of a successful/ideal project leader and 38% rated it second most important, followed by having "clear goals" (34% rated as most important). A proactive working style arrived on rank 3 (rated by 23% as third most important). Thus, 82% of participants identified effective communication as either the most or second most important factor. Overall, besides effective communication, clear goals and a proactive working style were the most frequently selected categories.

	The subgroup analyses by organization (Figures 3 and 4) and function did not reveal obvious differences in the results. Effective communication was the key characteristic rated by all analyzed subgroups as either the most or second most important characteristic.

	Representatives of pharmaceutical companies consistently rated effective communication (rated by 42% as most important, and by 36% as second most important), clear goals (rated by 31% as most important and by 29% as second) and proactive working style (rated by 32% as third most important) as the most important characteristics. Additionally, they rated dependability (rated by 12% as third most important) and long-term experience in clinical research (rated by 10% as third most important) of considerable importance (Figure 3).

	Contrary to pharmaceutical companies, CROs (Figure 4) valued risk awareness (rated by 16% as third most important) and dependability (rated by 15% as third) as one of the most important characteristics in addition to effective communication (rated by 48% as most important and by 38% as second), clear goals (rated by 34% as most important and by 23% as second) and proactive working style (rated by 22% as third most important). The value of a proactive working style was slightly lower rated by representatives of CROs as compared to pharmaceutical companies (22% versus 32% rated as third most important by CROs versus pharmaceutical companies).

	Fifty-three percent (i.e., 8 of 15) of representatives of the research and development medical functions from both CROs and pharmaceutical companies rated clear goals as the most important characteristic. Of notice is that the majority of respondents in this group selected effective communication as second most important characteristic only (rated by 20% as most important and 53% rated as second). This group valued the knowledge of drug development (20% rated third) and proactivity (20% rated third) that appeared to be higher as compared to other function subgroups.

	The overall results of the research and development function subgroup (both medical and non-medical functions) showed similar results defining clear goals (rated by 48% as most important) and effective communication (rated by 52% as second) to be at the top. A proactive working style (rated by 33% as third) and knowledge of drug development (rated by 19% as third) were on rank 3 and 4 of this subgroup.

	For the project and study management functions, effective communication was either the most or second most important characteristic (rated by 49% as most important, and by 36% as second), followed by clear goals (34% rated as most important and 27% as second). Risk awareness and dependability as the third most important characteristic were rated in 16% of cases reflecting the focus on risk management and trust in this subgroup of functions.

	As shown by different subgroup analyses, effective communication, clear goals, and proactive working style were considered to be the most important characteristics of a successful project leader. Knowledge of drug development, risk awareness, and reliability were rated as second most important by some of the subgroups in addition to communication, clear goals, and proactive working style. None of the subgroups and a very limited number of all respondents assigned a high value to long-term experience in clinical research, confidence-building personal skills, innovative behavior, as well as medical expertise.

	A number of educational textbooks on project management describe effective leadership as an essential prerequisite for project success. These textbooks provide comprehensive lists of project leader skills and competencies. While many sources provide representative data on technical skills, only limited data is available to characterize and evaluate the importance and role of personal/soft skills of successful project leaders. Most often this data is based on opinions of a limited number of project leaders and not based on large empirical research and representative surveys.

	Overall, only few investigations have been conducted to date to characterize the most important soft skills of successful project leaders, and a limited number of basic research studies has been performed so far, particularly in the pharmaceutical development sector.

	Aitken and Crawford16 evaluated the core set of behaviors of superior project managers (n=41). The essential behavioral competencies included delivering results and meeting customer expectations, planning and organizing, deciding and initiating action, leading and supervising, as well as persuading and influencing. Personality characteristics were consistent in rating as compared to behavioral competencies and included conscientious, vigorous, controlling, socially confident, evaluative, and persuasive. Of notice is that none of those characteristics specifically identified highly-developed communication skills as such as an essential competency.

	Skulmoski and Hartman described different competencies across all phases of the project based on 33 qualitative interviews conducted with 22 information systems project managers in Calgary, Canada. Communication competencies were identified as most critical during initiation, planning and closeout phases of a project.

	According to different sources communication or part of the skills related to communication are described as important or highly important. Thus, one of the critical skills that typically differentiates a project leader from a technologist is the ability to communicate well, both orally and in writing.

	The US DIA tutorial that induced the European survey presented in this article identified a proactive working style (47%, n=7), clear goals (33%, n=5) and effective communication (33%, n=5) as the personal characteristics of a successful project leader across the 15 respondents representing primarily the pharmaceutical industry

 who each was entitled to a maximum of three responses.

	In this survey, a large European panel (n=226) with experience in or exposure to project leadership in clinical trials confirmed the results obtained in the small US sample with effective communication assuming rank 1 ahead of clear goals and a proactive working style.

	The authors acknowledge the survey limitations due to restriction to soft skills of a project leader. Hard skills including education and expertise in the specific therapeutic area of project leaders have intentionally been disregarded. However, these types of skills are by all means considered to be a prerequisite and a minimum requirement for any project leader.

	It might also be argued that there was limited personal project management experience of a considerable proportion of survey participants. However, it should be noted that in view of their job functions all respondents must have been exposed to the performance of more or less successful project leaders. The results of this survey thus represent an external opinion of stakeholders of clinical development projects as well as own experience of executive project leaders.

	A next logical step would be to investigate how frequently current clinical project leaders are being rated as successful/ideal along the characteristics that came out as being of highest importance for project success, including their ability of handling different types of communication.

	Effective communication appears to be the key soft skill of a successful/ideal project leader far ahead of clear goals and a proactive working style. This conclusion mirrors the personal perception of 226 clinical research professionals representing predominantly CRO and pharmaceutical companies who work as project managers/clinical trial managers or are interested in this role. Long-term experience in clinical research and overall knowledge of drug development appear, however, to be less important for a project leader as compared to other knowledge, behavior, and skills. This outcome is in line with the rather scarce literature on the soft skill set of successful clinical project leaders. Required technical skills that are prerequisites for this job function were not subject to this survey.

	It appears to be mandatory that training programs offered to clinical project leaders attach high value to excelling in soft skills with a focus on effective communication and appropriate working style. The obvious aim would be to strengthen clinical development teams and boost the effectiveness of clinical development programs.

* MD, PMP, has worked at PPH plus as Project Leader. He is currently Clinical Research Physician at Boehringer Ingelheim, Biberach an der Riss, Germany, e-mail: 

 MD, FFPM, is Managing Director & COO at PPH plus, Frankfurt am Main, Germany, e-mail: 

	*To whom all correspondence should be addressed.

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