Guest Column | January 16, 2024

Balancing TMF Management After A Mass Layoff

By Nicole M. Palmer, CEO, Granular Level


In the ever-evolving TMF industry, we've recently witnessed a wave of mass layoffs within the clinical research profession that has left many talented individuals searching for their next chapter. It's a challenging time, no doubt. However, if you find yourself still standing in the storm, there's a unique opportunity to not only survive but thrive. Here are 9 immediate steps for you — to not only weather the uncertainty of the mass layoffs around you but to emerge stronger, smarter, and ready to grow in your next chapter.

9 Steps To Thrive During Staff Turnover

1. Be Grateful

First off, let's acknowledge the whirlwind. It's not easy seeing colleagues move on, but take a moment to appreciate your position. Gratitude is the cornerstone of resilience.

2. Lead Through Small Actions

Now, more than ever, your actions matter. Step up as a leader, even in the smallest ways. Offer support, share insights, and be the collaborator your team needs.  You could do this by mentoring others, hosting an internal webinar discussing the latest regulatory updates/trends, or suggesting an internal meeting to brainstorm ideas and leverage diverse perspectives. It's in the small actions that big leaders emerge.

3. Sharpen Skills

Use this time as an opportunity for skill refinement. Stay sharp. Whether it's conquering Excel, mastering the statistical method, or studying regulatory changes, being on top of your game adds undeniable value. By investing in yourself, you not only increase your personal value but you do so for the team and the company as well. As an individual, you refined your skills and increased your efficiency to streamline processes with team collaboration which overall benefits the company’s work.

4. Amplify Your Network

Leverage the power of your network, especially on LinkedIn. Send a connection request with a personalized message to those who've moved on, not just for professional gain but for the human connection. We're a community, and fostering those relationships pays dividends. Connect with industry peers facing similar challenges, exchange insights, and build a collaborative community.. Beyond connecting on LinkedIn, build meaningful relationships. If one of your connections is posting on LinkedIn, engage (like, comment, and or repost) with their post.

5. Innovate And Propose

With change comes opportunity. Be the catalyst for innovation within your team. Propose ideas, challenge the status quo, and show how you can adapt very quickly to anything that comes your way.

6. Develop Mental Toughness

It's okay to acknowledge the uncertainty, but let it fuel your mental toughness. Keep your mindset sharp, and remember, this too shall pass.

7. Optimize Resources

With fewer hands on deck, resource optimization is vital. Streamline processes, identify efficiencies, and champion initiatives that demonstrate the resilience of your team.

8. Embrace Change

Change is the only constant. Those who adapt quickly not only survive but thrive. Be the embodiment of flexibility and show that you're ready for whatever comes your way.

9. Avoid Drama And Gossip

It’s always your choice, so choose to avoid getting involved in office drama or gossip.  Clinical research teams rely heavily on collaboration and teamwork. Engaging in drama or gossip can create a toxic work environment, negatively impacting team cohesion and morale. Maintaining a positive, professional, and constructive image is crucial for career advancement. Engaging in negative behaviors during challenging times can be remembered long after the layoffs subside, affecting your professional relationships and future opportunities. Focus your attention and energy on becoming better by growing and learning. Rise above.

How To Manage The TMF With Staff Turnover

Now that we have covered how to personally “thrive and survive” with the layoffs, let’s go over how to manage the TMF with staff turnover. Being short-staffed can pose significant challenges with managing the TMF as the workload increases, especially as it comes to keeping it in an inspection-ready status. Let’s explore some strategies to effectively deal with staff turnover while ensuring that your TMF will be ready for inspection at a moment's notice.

Strategy 1: Assess And Identify Needs

The first step is to conduct a thorough assessment of the impact on the TMF’s management. Identify the former teammate’s roles and responsibilities within the TMF department and evaluate how their absence is going to affect the team, workflows, and document oversight.

Strategy 2: Prioritize Documents

Review the studies that you are assigned to and prioritize your essential documents. Focus on critical documents such as regulatory submissions for ongoing clinical trials. You want to ensure that all key documents receive immediate attention.

Strategy 3: Cross-Train On Other Skills

Now more than ever, cross-training is important among all TMF team members within the department. Some examples of cross-training could be in document management, TMF metrics/reporting, technology platforms that are being utilized, IRB/IEC submissions, risk management, corrective and preventive actions (CAPAs), or audit preparation. Encourage the team to share their expertise with their team members. This ensures that there’s some flexibility in managing different aspects of the TMF.

Strategy 4: Leverage Technology

Review your eTMF platform and make sure you are using all the capabilities it offers. You might have a feature turned off because it didn’t make sense to use it at the time, but you need it now more than ever. Look for tools like automation to help you organize and track your documents so that it reduces any manual work and reduces the risk of human errors.

Strategy 5: Develop A Staff Turnover Plan

Develop a plan for TMF management with the anticipation of potential staff changes. Here are a few key components you could include in your plan: a list of roles/responsibilities, knowledge handover session from the outgoing staff to current staff, cross-training initiatives, communication protocol, transition timeline, risk, and performance evaluation. Having a well-written plan in place will help the TMF team to adapt quickly to the staff turnover.

Strategy 6: Conduct An Internal TMF Audit

If your department went through a mass layoff or company restructuring, think about conducting an internal TMF audit sooner rather than later to assess the completeness and quality of the documents. This will help identify any gaps and identify areas for improvement and if there’s a need for a CAPA.

In conclusion, as you implement these steps and strategies, remember you must do your best to bloom where you are planted. By doing so, you are not just stepping into success, you are dominating TMF management during these challenging times.

About The Author:

Nicole M. Palmer is the CEO of Granular Level, a TMF consulting firm, specializing in TMF management and career advisement within the clinical research industry. With over a decade of experience, Nicole has developed and implemented efficient TMF processes, ensuring compliance with regulatory standards. She has navigated the complexities of TMF management, optimizing document workflows and providing strategic solutions to enhance overall trial efficiency. Connect with Nicole, who has been named by The Business Anecdote as one of the top five TMF experts to follow on LinkedIn, and learn more about her work at Granular Level.