Leadership Competencies Of A Clinical Trial Project Manager

By John Petrera

"Leadership competencies of a clinical trial project manager" is unique in that this qualitative inquiry research project not only explores the specific top leadership competencies of project managers involved in pharmaceutical clinical trials, but the concepts reviewed in this book are applicable broad spectrum to multiple professional fields. The proposed leadership framework combines elements of leadership competencies, project management competencies, personal competencies, and includes a review of the leadership types from the traits theory of leadership. The leadership concepts described are universal and can be applied to improve any leader's abilities.

While this book focuses on clinical trial project managers, the concepts and best practices apply to all PMs within pharmaceuticals or in any other field. The derived PM competency framework is transferrable to PMs in numerous industries and may also provide applicable guidance to others, regardless of their profession. Ultimately, the expansion of the PM triangle is a useful concept that many will find interesting. Additionally, personal competencies can improve personal effectiveness, achievements, and actions.

This project identified 5 themes to include (a) CTPM experience and knowledge, (b) leadership competencies, (c) leadership types (styles), (d) personal competencies, and (e) project management competency development (PMCD). The 5 themes identified are all critical to understanding the perspectives obtained from the study participants regarding leadership competencies to maximize efficiencies of research and development. The results of this study can (a) potentially assist new CTPMs, (b) provide a refresher for CTPMs seeking improvement, (c) provide support for project managers in general, and (d) may assist hiring managers in determining the leadership skills to seek. The results from this study may support the project, program, and portfolio managers from various industries to better understand the leadership competencies and the overall framework that support project management. At the same time, these 5 themes, interpreted in the broadest terms, may be helpful to you!

• Language: English
• Publisher: Fulton Books, Inc.
• Release date: Jun 17, 2024
• ISBN: 9798889820093

Book preview

Section 1. Business Problem and Project Scope

1.1. Introduction

The pharmaceutical industry is experiencing one of the most challenging business periods in its history. Large and small pharmaceutical companies need to learn how to expand the portfolio strategy, reduce costs, and increase flexibility in project management business operations. Critical components of project management business operations include reviewing transformational potential, focusing on project-related costs specifically, and considering internal opportunities that are not typically part of the company’s strengths (Schuhmacher et al. 2018). Pharmaceutical research and development (R & D) is the expensive, multiyear process of conducting discovery, research studies, and clinical trials (CT) to substantiate the safety and efficacy of a new drug compound. The long and complicated R & D process commonly leads to unsuccessful attempts to improve patients’ quality of life (QOL) since most new drugs fail to meet the risk-benefit ratios for safety and efficacy, thereby costing time and money while delaying patient benefits. Estimates have shown that an average new compound requires an investment of about $2.6 billion (Avorn 2015; DiMasi et al. 2016), success rates remain below 14% (Sullivan 2019; Wong et al. 2019), and the time from the laboratory bench to market requires at least ten to fifteen years of development (Challener 2017; Torjesen 2015). However, McNamee et al. (2017) determined a development median of about thirty-six years when the original technology initiation year was considered.

The area of interest was to explore the essential leadership competencies of clinical trial project managers (CTPM) needed to advance stakeholder relationships across clinical trial matrix organizations, as described by mid- to high-level clinical trial leaders in the pharmaceutical industry. Given the challenges of a clinical trial project manager to lead multiple functions without direct authority, the project intended to find methods of improving CTPM influencing skills with the hopes of improving new compound costs, timelines, and success rates. The project attempted to determine how a CTPM can be both an influential strategic business leader while at the same time managing and influencing the various scientific functions at an operational level across the internal clinical trial matrix organization and the external collaborators and vendors. The remainder of section 1 introductory section covers the capstone topic, problem of practice, and the project’s purpose, which includes project need, project questions, project justification, and project context.

1.2. Capstone Topic

This project was completed as part of a doctor of business administration (DBA) program specializing in leadership. The DBA in the leadership specialization at Capella University was established with eight core courses, four specialization courses, two residency courses, and the doctoral capstone. The eight-core courses included an introduction to doctoral studies in business, becoming a business researcher, applied business research projects, global operations, financial decision making, marketing in a connected world, contemporary issues impacting organizational success, and leading processes, technology, and people. The four DBA specialization courses included leadership theory and practice in a global environment, leadership as a personal practice, leading the organizational system, and leading dynamic systems with multidimensional thinking. The two residency courses included conceptualization strategies for applied business research and design and implementation planning. The DBA at Capella University concluded with the doctoral capstone. The capstone topic for this paper was to evaluate how a CTPM can better utilize influencing skills to lead research and development (R & D) teams to improve time, cost, and quality through the clinical trial process.

Successful project managers must lead without authority; in general, successful project managers possess strong influencing, leadership, and soft skills (Jeferson et al. 2018). This challenge is greatly enhanced in the CTPM role as the time, cost, and quality impacts are at a much higher level, and the stresses to manage between the operational/scientific level and the strategic/executive level are much greater. The capstone topic of improving CTPM leadership influence in the clinical trial matrix organization was aligned with the leadership DBA based on the aligned qualities of the DBA with the author’s interest and practitioner experience. The capstone topic uses qualitative inquiry with the potential to solve a real-world problem using existing knowledge. This capstone project was both manageable and feasible for the study of clinical trial project management leadership.

1.2.1. Problem of practice

The general business problem was that conducting clinical trials requires a significant amount of money, good fortune, and time as per appropriate safety and efficacy requirements. However, pharmaceutical companies often struggle with unnecessary delays, unanticipated misfortune, and additional costs related to completing clinical trials (MESM 2017). Estimates have shown that an average new compound requires an investment of about $2.6 billion (Avorn 2015; DiMasi et al. 2016), success rates remain below 14% (Sullivan 2019; Wong et al. 2019), and the time from the laboratory bench to market requires at least ten to fifteen years of development (Challener 2017; Torjesen 2015). The extensive time, costs, and lack of success directly negatively affect patients. The pharmaceutical industry strives to provide patients access to new potentially lifesaving medications and provide a high quality of life for a globally aging population while ensuring continued viability. While the general business problem requires significant changes in governmental regulations and substantial advances in scientific advancement, additional leadership challenges exist within this time trajectory, which influences the management of clinical trials.

The specific business problem was the ineffective leadership competencies of clinical trial project managers regarding managing internal and external stakeholders resulting in additional costs and delays to the clinical project (Banerjee 2017; MESM 2017). Hargreaves (2016) estimated that the financial impact could cost pharmaceutical companies between $600,000 and $8 million per day when additional project costs and projected lost sales were both considered. Nasina and Sai Nandeswara (2016) identified four reasons for cost increases in pharmaceutical projects. First, a lack of monitoring and controlling of the project schedule increased the time and resources needed to complete the project. Second, planning problems that increase the scope of the project would also increase the time and resources required. Third, activity-based problems, which are due to external forces like regulatory authorities (RA), can also increase time and resources. Fourth, estimation problems with vendors, collaborators, and project budgets can also affect the project planning (Nasina and Sai Nandeswara 2016). Managing the project schedule, project scope, project activities, project risks, and project estimates are all part of the role of a CTPM. The project manager’s lack of authority (Van der Schalie 2019), ineffective relational leadership (Moat 2019), and the inability to influence others (Van der Schalie 2019) can lead to extended timelines, higher costs, lost opportunities, lower success rates, and a potential lack of new medications for patients (Hale 2018). Given the project managers’ strategic and operational roles in clinical trials, the clinical PM is uniquely positioned to enable potentially significant improvements for the entire clinical matrix team (Banerjee 2017; Moat 2019). The objective of this practitioner project was to explore, through constructive interviews, how CTPMs can be more effective influential leaders, thereby leading to a reduction in timelines and costs while improving the probability of success.

1.3. Purpose of the Project

The purpose of this qualitative inquiry project was to explore the perspectives of mid- to high-level pharmaceutical company leaders within the United States as to the CTPM leadership competencies that minimize the time and cost of clinical trials.

1.3.1. Project need

Large pharmaceutical companies need to learn how to expand the portfolio strategy, reduce costs, and increase flexibility. Such improvements include reviewing transformational potential, focusing on project-related costs specifically, and considering internal opportunities that are generally not part of the company’s strengths (Schuhmacher et al. 2018). CTPMs can lead the change management required for each of these needs, but project managers must accomplish this from a leadership position without formal authority. The CTPM needs to influence the clinical trial matrix organization internally and with collaborators and vendors externally. The function of a general project manager is to manage, lead, and influence without authority; this has been well established (Clayton 2015; Kyle and Tittel, 2016). The CTPM is still required to lead without authority throughout the potentially decades-long clinical trial management process where the cost, quality, and timelines are considerably enhanced, and patients’ lives are the primary concern.

Even though CTPMs lack direct authority, CTPMs are uniquely positioned to potentially lead the change management required for each of these needs since CTPMs are also the de facto change agents for the organization. Change management requires strong soft skills, which were also identified as necessary for project success (Vitale 2017; Vogler et al. 2018). For CTPMs to be successful strategic, operational, and change management leaders, effective soft skills were evaluated. The intended outcome of this qualitative inquiry project was to produce a series of recommendations for how the CTPM can be a more effective influential leader, which focuses on potential improvements in strategic thinking, change management, communications, and soft skills. These improvements may lead to the desired results of reducing timelines and cost while simultaneously improving the probability of success for clinical research and development, thereby enabling patients to live better lives potentially.

1.3.2. Project question

What are the perspectives of mid- to high-level pharmaceutical company leaders within the United States regarding the CTPM leadership competencies that minimize the time and cost of the clinical trial development process?

1.3.3. Project justification

A gap in practice is often derived from a CTPM lacking leadership competencies in soft skills, influencing, and change management (Kuhl 2018; Van der Schalie 2019). The lack of strategic thinking is another common CTPM leadership competency shortfall causing a gap in practice, often leading to a failure to plan accordingly (Banerjee 2017). From 2005 to 2015, R & D efficiency globally decreased instead of increasing to meet the future desired state (Schuhmacher et al. 2016). Project management teams need to be adaptable for big pharma and smaller biotech firms. CTPMs need to evolve accordingly to include the ability to be leaders, to be proactive, to be a change agent, to be flexible, and to be inspirational (Hack and Sackner 2016). Additional evidence to support the gap in practice can be observed from new methods of planning, scheduling, executing, and controlling projects that should be considered (San Cristóbal et al. 2018). Finally, project manager communications need to be improved since structured communication systems were identified as lacking (Vitale 2017). Collectively, CTPMs need to improve strategic thinking (De Haaff 2020), change management, communication skills, and soft skills to influence others in the clinical trial matrix team, thereby improving the potential for success through effective team collaboration (Van der Schalie 2019). This project aimed to identify the key leadership competencies required of the CTPM to address the gap in practice.

CTPMs have struggled to maintain initial clinical trial timelines and budgets. At a minimum, potential unplanned delays should be identified as part of a risk management plan with timeline and budget considerations included. This project intended to identify effective leadership competencies needed to minimize additional time and costs to clinical trials created from a potential CTPM knowledge, skill, or practice gap. This gap in practice is likely due to a lack of clinical trial experience, knowledge, training, and strong leadership (Moat 2019). Another cause could be the lack of competence, including the proper methods and tools needed to succeed (San Cristóbal et al. 2018). A common CTPM mistake is to be too optimistic in planning. To avoid this, a CTPM must have the knowledge and skills to work with clinical operations, regulatory, manufacturing, and other functions to coordinate realistic timelines properly. This optimistic planning often leads to a conflict between science and business strategy. However, a skilled CTPM needs to balance all these needs. The