Thoughts on the Care and Feeding of Your Organization’s Future Leaders

Clinical Researcher—March 2021 (Volume 35, Issue 2)


Christine Senn, PhD, CCRC, CPI, ACRP-CP, FACRP, CSM


Many organizational behavior thought leaders—top among them today probably John Maxwell and Simon Sinek—have written at length about what it takes to be a strong leader, and, from what I’ve read, they’re all right. Being a strong leader is a complex dynamic in which there are many possible characteristics, skills, and tactics one can choose to develop. There is no one set style or way of being that defines a great leader because we not only have to choose what is authentic to us as unique individuals, we also must embrace a style within the context of our company’s culture.

I believe that chief among the key characteristics of a strong leader are knowing your own strengths and weaknesses, and having strong emotional intelligence so you hire people who work symbiotically together and who support the company’s desired culture.

More specifically to clinical research leadership, however, I focus training myself and our company’s managers on the following skills: setting expectations, providing quality feedback, and having difficult conversations.

Setting Expectations

People are not mind readers. What I have experienced as a psychotherapist (and from attending a few operas) is that misunderstandings can be devastating. How many fights have you had with a partner because of a misunderstanding? As an example, perhaps my definition of being on time for a date is that you arrive exactly at the time we discussed, but your definition is that you arrive no more than an hour late. There’s going to be a fight!

I see managers make this error when they assume their employees are like them. I also see this error when managers have forgotten what it was like to learn their jobs. Managers have to constantly set reasonable expectations, coach their people on how to meet those expectations, and (as much as possible) ensure their people’s success. It’s a linear process comprised of setting up one’s employee for many small successes to foster their sense of confidence.

A leader’s role is a bit different. We do have to set expectations for anyone we manage, but I see a leader as being more of a mentor. (To keep our expectations aligned, I’ll tell you what my definition of that is.) Anyone can display these leadership-mentorship behaviors.

A mentor gives very specific feedback on something done well, as a way of reinforcing that behavior. A mentor also gives very specific feedback on something that didn’t go well, but with no malice or negative implications, just a learning opportunity. Mentors open themselves to being asked any question about anything in the company. When they don’t know the answer to a question, mentors use the opportunity to teach employees how to find the solution. A mentor is in the business of directing people to resources, rather than giving them answers.

A mentor also demonstrates the company’s values in everything he or she does. I don’t think I’ve ever seen our CEO walk into one of our clinics without picking up a piece of trash that was laying on the ground in the parking lot, because—even if we share the building—it’s a reflection on us. That might not be mentorship in your company, but we have a core value that Appearances Matter, so it’s very much one of ours.

A mentor is someone who shows people a vision of what is possible. The vision I offer, for example, is to show others what implementing our CEO’s vision well looks like: It looks like meeting our clients’ enrollment goals. It looks like amazing study startup timelines. It looks like phenomenal customer service by responding to our clients with grace and thoroughness. It looks like having a team of specialists who work together to ensure the highest quality data. It looks like collaborative teamwork that far surpasses anything you’d see on a motivational poster.

Every manager and every employee has his or her own vision. My opinion is that a leader’s job is to not leave those visions to chance. Help people see the vision you want them to see, and show them that you embrace the greatness you want them to achieve.

SIDEBAR: Ingredients You Should Keep in Stock for a Strong Process Improvement Brainstorming Team

  • At least one creative thinker, regardless of the person’s role in the company.
  • At least one person who knows the current process intimately.
  • Two people who somewhat know the process but, more than that, embrace keen interest in process improvement.

In small companies, these can be overlapping people. In large companies, invite more people, but keep a balance as described above. Mix well and serve.

Providing Quality Feedback

Our industry is difficult to learn, with all its complicated regulations and procedures, puzzling acronyms, and scientific complexities. It’s also an industry that few people have knowledge of before entering it. Given this environment, rather than annual reviews, I strongly recommend that any leader implement monthly reviews—whether just for his or her people or, if in a position to do so, the entire company. It sounds overwhelming at first, but such frequency offers many benefits, and having people do well at their jobs saves more time than monthly reviews take.

Monthly reviews help ensure your employee is exhibiting the soft skills expected for the job, is completing the tasks expected of the job, and is supporting customer service by showing your clients the best of your company. What is the damage done to your company if a client doesn’t think you’re responsive? If they think you’re difficult to work with? What is the effect of not having people complete their tasks, and you not realizing it right away? We have had trials where sponsor representatives have never sent us follow-up letters (despite our haranguing), and the project manager has had to tell us as the trial closed that, since the person responsible didn’t do their job, we won’t have any letters for our trial master file. That’s not good for the sponsor or the site, and the U.S. Food and Drug Administration is not happy to learn of such situations.

There are simply too many moving parts in clinical research, and this is made all the more complex now with fast-moving COVID-19 trials. Going several months without verifying a person’s work and documenting their accountability is a management mistake that can create vast leadership problems.

Having Difficult Conversations

Some people find difficult conversations to be frightening or rude. In fact, at least one study{1} suggests that nearly 70% of people avoid difficult conversations in the workplace. This leads to low morale, a toxic work environment, and damage to organizational performance and profit margins.

I follow the school of thought that every issue is either a “people” problem or a “process” problem. The only way to solve either one is to have an honest conversation. (The 70% of people who avoid these conversations are frankly not going to be good managers or leaders.)

The most critical tip is to always assume first that you have a process problem. Go into any situation wondering how to brainstorm the problem so that the process improves. I create many brainstorming meetings with people I think can contribute to improving the process. It’s not the same people every time, because that would become stale; it’s always people who either are creative brainstormers by nature, or who know enough about the process to think about how it could be done differently without becoming entrenched with their particular idea. Improving a process fixes nearly every issue.

If the process has been improved and most everyone is doing well with it, those who aren’t are the problem. You have a couple of options here. If you avoid an honest conversation, you will watch the person continue to perform poorly, in which case you will ultimately terminate them for poor performance, or they will leave because they feel like a failure. Your company or your department will suffer the entire time.

Instead, be brave. Have the difficult conversation with the person, and do so from a place of trust and acceptance. No matter how poor someone’s performance, I’ve never met anyone who has done poorly on purpose. People genuinely want to succeed. They might make bad choices, but that probably means we didn’t give them enough information to make good choices. They might prioritize tasks inappropriately, but that’s on us as leaders for not sharing our vision with them.

If you go into these conversations truly believing that you and the employee have the best interest of the company at heart, then a difficult conversation isn’t all that difficult. You’re trying to help them save their job; you’re trying to make you clients happy; you’re trying to make the department or the company better. There’s absolutely nothing negative in there, which is why I don’t personally ever find a conversation difficult.

Worth the Effort

I’d like re-state that anyone and everyone can be a leader. There is no time like the present to train yourself how to set expectations, provide quality feedback, and have difficult (or shall we just call them honest?) conversations with your coworkers or your supervisor. These skills demonstrate leadership and can lead to promotions—and they usually have the extra bonus of bringing additional satisfaction into people’s personal lives.



Christine Senn headshot

Christine Senn, PhD, CCRC, CPI, ACRP-CP, FACRP, CSM, is Chief Implementation and Operations Officer with IACT Health and a member of the ACRP Association Board of Trustees.