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OUTSOURCING Often, the leader does not intend to make


errors or be ineffectual. I’m not talking about good leaders who encounter matters that cannot be overcome, managed or even forecasted. Nor am I speaking of good leaders who make the wrong decision with the best intention. Mistakes happen often, and we should all be able to work from a place of psychological safety, having the freedom to take risks and make errors. I have taken Stephen R Covey’s The 7 Habits of Highly Effective People and flipped the script, creating ‘the seven habits of highly ineffective clinical research leaders’.


They’re not in charge


The first of these habits is not taking charge. When you ask a large group of people to raise their hands to, ‘How many of you in this room are leaders?’ Often about 20% of people will raise their hand. Why is this the case? Empowerment. They don’t feel like they are in charge or can influence their tasks, they lack a strategic perspective and don’t understand the mission. Working with clarity on the goal empowers leaders to have more freedom to take risks and achieve results faster. Working with ambiguity creates indecisiveness, moral disintegration, quality issues, timeline extension and increased project cost. In Linchpin, by Seth Godin, he describes one of his


talks to a group at the FDA. This collection of leaders works tirelessly to identify ways to navigate multiple competing priorities and timelines, all the while searching for ways to improve innovation and reduce bureaucracy to bring new drugs to ailing people. After speaking to the group, one of the enforcement officers – who wears a badge – raised their hand and said, “They want us to invent a new future and to lead tribes and to make a difference, but we don’t have the authority. I can’t get anything done without authority.” To which Seth replied, “How much bigger do you need your badge to be?” The point is no one permits you to be in charge.


You take it or you don’t. Take responsibility for the task and empower those around you to achieve it.


They are order-takers The second habit is doing exactly as you’re told, exactly as the protocol is written and exactly as the standard operating procedure (SOP) instructs. We work in a highly regulated environment where guidance documents and practices are a way of life. Analytical labs have procedures to


“The best resource for good leadership is through building relationships and being intentional about learning positive behaviours.”


They focus on the problem instead of the solution These are the finger-pointers, the perfectionists, the leaders who want to ensure that someone, or something, is at the heart of their root-cause analysis. The problem with this habit is that, even when their findings are accurate, there is ineffective action in response. The finger-pointers get derailed easily; they are sure to find a flaw in your plan – they look for the error. When they see it, we applaud them for their attention to detail. Finding the error and fixing it, isn’t enough.


In taking the next step, we should always be tweaking and improving the process. When was the last time a protocol template was updated? I have seen the same time and events schedule for past 20 years. Effective leadership takes the problem, fixes it, innovates and acknowledges the progress that was made.


They’re provincial Have you ever had that one phone call you didn’t want to make because you knew the chaos it would create, just by opening your mouth? Imagine something like this happening at Boeing. The pilot, or mechanic, sees a problem and needs to escalate the issue to the boss. But the leadership is so territorial that the person who identified the problem decides it’s best to keep it to themselves.


Outsourcing in Clinical Trials Handbook | 11


follow; data managers follow the specs; and CRAs monitor to 100%.


But none of this solves problems. We are in a


framework of ‘do no worse’. We are in a framework of ‘do no worse’ but operate in an industry where it is crucial to innovate, but we are scared to do so. If we continue to operate this way, we will get


what we have so far: the same. It takes courage to take risks; it is incumbent upon us all to allow room for this risk, to take advantage of the innovational prowess it will create. The leader who finds success will be the one who cultivates this culture, they will ask in-depth questions that cut through the noise and they will act upon the answers they find.


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