Workforce Development Transformation and Implementation: The Critical Role of Leaders in Success

Picture of Erika Stevens, faculty lecturer at Rutgers Clinical Research Management and Principal of Recherche Transformation Rapide. LLC

Erika Stevens, MA, FACRP

Faculty Lecturer

Rutgers Clinical Research Management


Recherche Transformation Rapide LLC

Picture of Liz Wool, President of Wool Consulting Group, Inc.



Wool Consulting Group, Inc.

Abstract: The role of leaders in successful implementation of a workforce development program is often overlooked. Notably, change management and the leader’s fluency in implementing change is necessary for success. This article describes the critical attributes for leaders to be able to manage and implement workforce development for their organizations, and for leveraging transformation management principles and practices for success.

Disclosure: The authors have no relevant financial relationship(s) in connection with this article.


A leader’s management of employee specific roles, job descriptions, training, and development plans can better equip the employees to perform on the job. Effective leaders require one-on-one meetings with employees, they set goals for the year, they conduct performance reviews, and they provide feedback to their employees.

The Role of Leaders in Workforce Planning and Development Strategy

When conducting clinical research, workforce planning includes more than job skills and behavior management. The first step, workforce analysis, requires analyzing the current workforce and comparing it to the organization’s direction for research. Workforce analysis involves evaluating what is happening in the marketplace in terms of the labor market and considering internal workforce characteristics and capabilities. Figure 1 provides an overview of the workforce planning cycle.

The second step is forecasting future needs, which involves identifying future business needs, scenarios, and future workforce characteristics and capabilities. This could include forecasting what would happen if the clinical research site grows rapidly or if the research portfolio slows down. Forecasting helps ensure that leaders always have a talent pool available and offers the capability to recruit more talent.

To plan accordingly, the third step, requires leaders to identify and analyze the gaps between future workforce needs and the current workforce. Step four requires the development of strategies to support workforce development. Examples may include partnering with human resources to address the gaps between the current workforce and future workforce needs. This process requires integration of business and human resource strategies. Capable staff in human resources can serve as partners to leaders. Human resources personnel are often expert in workforce development and may be able to support leaders in this process. Partnering with human resources provides a quick start to workforce planning and development and may eliminate the need for leaders to determine how to do this on their own.

Step five in the workforce planning cycle includes implementation strategies. Examples may include investment strategies and change management strategies to address issues. Making an investment could be necessary over many months or years. Critical change management skills include project management and communications, and inspirational and motivational proficiency. Finally, as with any business process, leaders must also monitor and evaluate the effectiveness of their strategies to determine the success and impact of planned changes on performance. The workforce planning cycle must be repeated continually.

Workforce Development Strategy

Identifying the steps and processes for staff development requires examination throughout the organization. Specifically, developing staff performance standards for every role at every level is the first step. For example, in reviewing the informed consent form, the requirements are different for the regulatory professional and for the clinical research staff member who is executing the informed consent process. Standards must be developed for the entire process that is being performed. Figure 2 provides an overview of workforce development strategy.

The second strategy step requires leaders to identify the necessary knowledge, skills, and abilities. Abilities include critical thinking, problem solving, and initiative. The Multi Regional Clinical Trials (MRCT) Joint Task Force for Clinical Trial Competency developed a competency framework model for clinical research professionals.1  This model documents and describes fundamental skills in clinical research and is included in workforce development strategy as step three. 2,3   

Next, understanding the expectations for the workforce is important.4 Clinical research staff must support organizational performance and business needs. Leaders understand that clinical research staff are working for a greater good. They are bringing new products and therapies to mankind.

Another critical step in workforce development strategy is the management and oversight of change.  Leaders must understand processes for managing and overseeing change, and the drivers for inspiring other people to change. Embedded within this step are a change management plan, a project plan, a risk management plan, and a communication plan. 

Risk management is a common need in clinical trials, and is necessary for workforce development as well. The risk management plan covers things that could potentially happen to derail the workforce development program and how to manage them for success. The communication plan is critical and should be customized for clinical research staff.

The next two steps in workforce development include; 1) equipping clinical research personnel to meet defined competencies for success and 2) developing performance measures for continual improvement. Stakeholders throughout the clinical research workforce must have clearly defined responsibilities and duties.  Finally, the last step requires the monitoring of internal and external factors, while measuring actual results.  Leaders should periodically conduct evaluations to aid future initiatives.

Organizational Implementation

Implementing the workforce development strategy starts with defining the requirements of each role and reviewing the workforce development and training plan. Training should be customized and tailored to clinical research staff needs.5

Change may be unsettling and leaders need to provide support for the clinical research staff in order to facilitate implementation. Providing coaching, mentoring, and opportunities to learn one-on-one from designated subject matter experts supports change.   

An effective leader understands the “why” for the workforce development strategy: the goal, the purpose, and the expected results. While the rationale is consistent, keeping stakeholders apprised throughout the research enterprise is necessary. It is important to understand the roles that will be impacted by workforce development activities. Leaders’ review of a gap assessment between the current state and the required future state is required.

Organizational intelligence (robust grasp of the organization), coupled with effective communication planning and delivery skills, fosters implementation success. Messaging should be customized by role. People at all levels need to know “why” the changes. Leaders should plan conversations and develop scripts for conversations with clinical research staff. Discussions should be positive and should be used to diffuse any negative situations. If individualized communications are absent, there is a good chance that the proposed changes will fail.  Leaders who understand and leverage change management practices will have greater change management success. 

Critical Attributes of Leaders

In addition to mastery of communication techniques and change management strategies, leaders must be positive, creative, and motivating.  Figure 3 identifies leadership attributes.  Leaders who maintain a positive stance and who are energetic, who exude confidence, and who keep an eye on the change process, are better equipped for workforce development transformation management. 

INSEAD6 strategy professors W. Chan Kim and Renée Mauborgne defined competitive advantage as the “pursuit of differentiation.”7 In defining “Blue Ocean Strategy,” being the first with a novel product or service provides ample opportunity.  On the contrary, “Red Ocean” is saturated and limits innovation.  When entering a new space, successful organizational leaders seek blue ocean strategies versus red ocean strategies. One of the best attributes of a leader is the ability to keep an eye externally focused in order to be aware of what is happening in the marketplace.

Further, strong interpersonal skills are critical for successful leaders.8 These, so called, “soft skills,” leverage on-going communication tactics to motivate employees, even when there are pitfalls and delays.

Other soft skills required for leaders include negotiation and problem solving abilities. Leaders must be able to successfully negotiate with different stakeholders in the process of workforce development. Problem solving is a key soft skill needed for moving forward with a successful clinical research program.

In 2019, Cengage Group surveyed 650 employers and more than 1,500 current and former college students examining hiring capabilities.9  The survey measured the ideal criteria organizations seek in employees. The survey asked about technical skills, quantitative skills, and soft skills. The college students responded based upon feedback they received from employers while looking for jobs.  While technical skills were important in clinical fields, Cengage Group found that more than 65% of the time, employers are evaluating soft skills. 8  

Similarly, Lyu and Liu analyzed a proprietary job posting dataset from 2010-2019 and identified increasing evidence of “soft skills.”10 As a leader, soft skills are critical for transformation management. Soft skills enable a leader to continue to progress, and to move successfully along the continuum to promote the workforce within the clinical research industry.

Another vital attribute for a leader is agility. This includes the ability to pivot; to be innovative, to be flexible, to be reflective, and to accept feedback. Leaders need to be able to shift from one project to another swiftly and with ease. Similarly, workforce development requires innovation and creativity. Leaders need to be able to think about new ways to develop the workforce and how to create energy.

Expanding further, flexibility is required, as not all plans will procced as first intended. Workforce development is increasingly challenging. Leaders need to be able to stop and reflect on what is working and is not working.  Garnering and accepting feedback from individual stakeholders and their teams is a requirement.

Based on feedback received, leaders are expected to pivot. For example, a leader may plan to implement an entirely new solution or update a capability or a function. If this implementation does not go according to the plan, the leader has the obligation to change course. 

Leaders with change management expertise will maintain innovative and creative approaches, while having the confidence to leverage successes and to assess and overcome gaps because workforce development gaps may change over time and may not be as expected. Workforce development also demands alignment to the organizational strategy and will succeed if tied to overall goals.


Leadership in motivating and engaging clinical research teams is crucial for success. Involving stakeholders and balancing the push/pull of staff demands, requires leaderships’ self-assurance. Adaptability, flexibility, and the ability to pivot are important qualities of change management leaders. Effective leaders review a work plan and its progress, and recognize any needs for change, even if the change is not in the original scope of the project. Finally, workforce development is not a singular process or a siloed activity, it also requires marketplace awareness.


Workforce Planning Cycle


Workforce Development Strategy


Critical Attributes of Leaders

  1. Multi Regional Clinical Trials Joint Task Force for Clinical Trial Competency. JTF Core Competency Framework for Clinical Research Professionals. Accessed 4/28/23.
  1. Sonstein S. et al. Moving from Compliance to Competence: A Harmonized Core Competency Framework for the Clinical Research Professional. Applied Clinical Trials, June 2014.
  2. Speicher L, et al. The critical need for academic health centers to assess the training, support, and career development requirements of clinical research coordinators: Recommendations from the Clinical and Translational Science Award Research Coordinator Taskforce. CTS Journal, 2012(5):6. Accessed 4/28/23.
  4. Wool L. Let’s Focus on the Learner, Education and Training in the 21st Century, Paradigm Shift to Performance. The Monitor. February 2011.
  7. Crosbie, R. 2005. “Learning the Soft Skills of Leadership.” Industrial and Commercial Training 37(1):45-51.
  2. Lyu, Wa, Liu, J. 2021. Soft skills, hard skills: What matters most? Evidence from job postings” Applied Energy 300 (15)   b

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