In the battle for the war on talent, biopharmaceutical companies, particularly those in competitive markets, are having to find creative strategies to enhance their staff recruitment, engagement and retention practices.^1,2 In the 2018 Employee Tenure Survey conducted by the U.S. Bureau of Labor and Statistics, it was reported that the median tenure for wage and salary workers was 4.2 years and this has not changed in a decade.³ The tenure is even lower in the healthcare industry clocking in at 3.5 years for the category of “health services, except hospitals.” While this may not directly correlate to roles in clinical research, it highlights the challenges that managers and organizations face when it comes to developing and retaining talent. Should companies play an active role in investing in their employees’ growth and development? What practical approaches should employees take to ensure they have a targeted plan for growing the knowledge and skills most needed to be successful in their role? What is the best way to communicate the competency expectations of employees and set them up for success, so they perform and grow in their roles and stay with the organization? And, in a large organization with multiple managers, how can consistency in the interpretation of these expected competencies be ensured? These were but a few of the questions that the clinical operations group at Genentech has tackled over the last few years. In this article we provide a case study for how we went about addressing these workforce challenges, where we are and what we learned along the way.

Goals and objectives of the initiative

Genentech, a member of the Roche Group is headquartered in South San Francisco, a hotbed for high-tech and home to many biopharmaceutical companies. Roche, like many organizations, functions around a set of core competencies that outlines the cultural and organizational behaviors that are expected of all employees including such teamwork and collaboration, decision making, and innovation. These competencies include both technical (e.g. achieving results) and leadership (e.g. communication) competencies. These core competencies provide expectations for the skills, behaviors and knowledge (SBKs; sometimes also referred to as Knowledge, Skills, and Abilities—or KSAs) that employees should demonstrate and master to fulfill Roche’s overall corporate objectives.

As part of a larger initiative focused on developing, retaining and shaping our study management leaders to build the culture of tomorrow, Genentech’s early research and development (gRED ECD) clinical operations group wanted to address long-standing feedback from employees and managers on the lack of a consistent framework for mapping the Roche core competencies. Additionally, the group struggled with the lack of a standardized way of defining these competencies across all jobs and job levels.

To address these issues, gRED partnered with the Association of Clinical Research Professionals (ACRP) and embarked on a journey in 2018 to ideate and develop a solution. The “Competency Framework Initiative '' (herein referred to as “the initiative”) was started with some of these immediate needs in mind along with a recognition of the larger challenge of securing, growing, and retaining talent in a highly competitive market. 

Specifically, the goals of the initiative were to:

• Provide a standardized and consistent way of tying the Roche Core Competencies to key job responsibilities across all job levels within study management
• Develop a multi-purpose guidance tool for all managers and employees for:
  • Clinical operations managers and their direct reports to take a more targeted approach in identifing areas of strength, development, and growth (goal setting)
  • Clinical operations employees and managers to have a systematic and standardized way to evaluate the competencies at their existing job level and assess the talent pipeline
• Provide learning “playlists” that match the descriptions defined in the core competencies to aid in easy identification of learning resources
• Update job descriptions to align with the SBKs outlined in the framework

More broadly speaking, the competency framework and associated training and competency-based job descriptions were expected to be a powerful tool to empower and motivate employees to take charge of their development and use the framework to refine their development plans. In essence, the initiative was designed to help our employees identify areas of focus and to generate clarity on the competencies in each role.

Methodology and approach

The study management function within gRED consists of four different job roles ranging from an associate Clinical Trial Leader (CTL) to a senior and principal CTL. Specifically, these roles span a broad range of clinical trial leadership and technical responsibilities.

The initiative was a multi-step approach that involved the following:

• Step 1: In collaboration with ACRP, a small group of managers (herein referred to as “core team”) reviewed the competency domains and developed definitionsfor theskills, behaviors and knowledge (herein referred to as SBK) requirements for each of the competency domains outlined in the Roche Core Competencies for each of the three job roles in study management. Due to the monumental nature of the task and ACRP’s experience in developing role-specific competency guidelines⁴, gRED contracted with ACRP to provide consultation and support throughout the project
• Step 2: For thoroughness and robustness of the framework, the core team compared the technical and leadership competencies against the harmonized core competency framework developed by the Joint Task Force for Clinical Trial Competency (JTF)⁵, ACRP’s Competency Guidelines⁴ and added additional technical and leadership SBK statements
• Step 3: All managers participated and were engaged in a sprint workshop to review the exhaustive list of SBK in each competency domain and consolidated them into a manageable and succinct list.
• Step 4: This list was translated into an easy to digest spreadsheet format
• Step 5: In partnership with the Learning and Development (herein referred to as L&D) group, a small subset of managers and their direct reports (at each of the three levels of study management) piloted this framework and provided feedback
• Step 6: The framework was further refined based on the feedback from the pilot attendees and finalized 
• Step 7: The finalized framework was shared with managers; an FAQ was developed to aid managers in the roll-out and “office hours” held to answer any questions
  • Note: The framework was shared with study management via email and discussed at a forum
• Step 8: Check-in meetings were held with managers to answer any questions and incorporate any feedback post launch

Figure 1. Competency Framework Development Process Steps

Progress to date and next steps

We are currently in the process of:

• Updating the job descriptions to ensure that talent is hired to the same standards defined in the framework and to ensure that our job descriptions reflect the skills, behaviors and knowledge of our workforce
• Developing the training “playlists” to give employees an easy access to all available learning resources

We plan on updating the defined SBKs within the framework based on feedback from managers and employees. Additionally, we recognize that this effort was unique for the industry, in terms of creating a competency framework for clinical trial leaders. ACRP plans to build upon aspects of the CTL competency framework as they expand their competency resources.

What we’ve learned

Transitioning from traditional job descriptions and performance assessment tools, to a competency-based roadmap for staff development and assessment was both challenging and rewarding for the core team. Some key take-aways from our experience include:

• While some industry-standard competency guidelines exist for other clinical research professional roles (CRAs, CRCs and Investigators)⁴, there were very few competencies that we could incorporate into the more advanced SBKs required of a clinical trial leader
• It's easy to go overboard—adding too many sub competencies can make the framework cumbersome and can lead to issues with adoption
• It is very important to bring all managers along in the process; the core team continuously solicited feedback from all managers in sprint sessions along the way
• It is prudent to run a small pilot to gather feedback from direct reports and managers to
  • gather frequently asked questions about the framework and its implementation
  • refine the defined sub competencies (e.g. delete repetitive or add missing sub competencies)

Summary and conclusions

Creative approaches are needed to address the clinical research workforce “talent wars”. A business-as-usual mindset won’t solve the problems, but a competency-based approach offers many benefits to the employer as well as employee. While every organization will adopt their own approaches to developing their talent, we hope that the methodology discussed here provides some practical guidance for those embarking on a similar journey.

While innovative hiring and engagement tactics may offer a competitive advantage, making investments in our staff is just the right thing to do for the patients we are trying to serve.

We look forward to sharing updates and lessons learned as we gain further experience with this initiative.

Sarah Hamirani is the Senior Clinical Program Leader at Genentech, a member of the Roche Group. Beth Harper is the Workforce Innovation Officer at the Association of Clinical Research Professionals.

References

1. Harper, B. Talent Talent Wars: How To Develop A Competent Clinical Research Workforce In A Competitive Environment. Clinical Leader. https://www.clinicalleader.com/doc/talent-wars-how-to-develop-a-competent-clinical-research-workforce-in-a-competitive-environment-0001. Published December 18, 2018. Retrieved March 6, 2020.
2. Henderson, L. Catch (& Keep) a Rising Star: Clinical Research Talent Trends. Applied Clinical Trials. http://www.appliedclinicaltrialsonline.com/catch-keep-rising-star-clinical-research-talent-trends. Published March 1, 2018. Retrieved March 6, 2020.
3. Bureau of Labor Statistics Employee Tenure 2018. U.S. Department of Labor. https://www.bls.gov/news.release/pdf/tenure.pdf. Published September 20, 2018. Retrieved March 6, 2020.
4. ACRP Partners in Workforce Advancement; Define, Align and Validate Competence Standards. https://acrpnet.org/acrp-partners-in-workforce-advancement/acrp-partners-in-workforce-advancement-define-align-validate-competence-standards/
5. Joint Task Force for Clinical Trial Competency. https://mrctcenter.org/clinical-trial-competency/