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OUTSOURCING It’s often difficult to accept new ideas. We get so


focused on the process that we lose sight of the goal. We perform 100% source data verification but miss our primary end point. We use quality control and quality assurance to prove to ourselves that we are doing things correctly, never considering whether or not we should be doing them at all.


They are firefighters I have been guilty of this for years, as I responded to a question about how things were going with a proud retort of ‘putting out fires’. The reason being is that I felt it was what the job was all about: finding problems, solving them and filing them away for an annual review. There’s a tendency to put a process in place and then sit back to watch it work. Using a clinical protocol as an example, it doesn’t help that even if we foresee a problem or a way to improve the process, it takes time and money to correct it. I’ve often heard during initiation visits from study


coordinators that we should have consulted them before finalising the protocol. With their firsthand experience, they have a vast amount of knowledge about what actually works. There is a tendency at pharma companies to create the protocol in a vacuum. When all the while, the answer to your problems was with your stakeholders. Instead of putting out fires, leaders need to be finding novel ways of preventing fires. The number one way I have found that works is to ask better questions. Ask the people who the decision will affect instead of guessing. Have the courage to ask a question and seek out new technology. If this is not your area of expertise, listen to what others are saying. Find the people interested in this space and see what they’re doing. Chances are, they are sitting closer to you than you think.


They’re perfectionists Trained as a clinical research associate since I joined this industry, my eyes tend to drift towards the error.


Noticing these errors is a distracting habit. Perhaps


it’s human nature to see something out of order and crave to put it in its place. Noticing and even correcting these errors, however, does not improve the process necessarily. There are always exceptions – for example, 2.0mg is not the same as 0.2mg. However, when the fact-finding mission turns into analysis paralysis, we lose sight of the goal and miss critical end points along the way.


12 | Outsourcing in Clinical Trials Handbook


This style of leadership is uninspiring and has little chance of being motivational. If you are the type of person that loves spotting the spelling mistake, ask yourself first: by providing my comment right now, am I improving the process? If the answer is no, move on. Make a note and come back to it.


They’re poor communicators Lastly, the final habit of ‘highly ineffective’ leaders is communication. There has been a lot of discussions lately about communication in the wake of the global pandemic created by the Covid-19 virus.


The people in discussion solely use email, silo themselves and prefer working independently, which is not helpful – especially in a crisis. When they do speak, it is not in a tone that is readily accepted or lacks clarity.


Perhaps for these leaders, it is an unintentional learned behaviour. It could be fear-based, which is not inherently wrong because then there is room for improvement. Rarely is it done out of malice or hostility. How much stock is put into leadership training anyway?


Conclusion Which brings us to the question: What can we do to improve? If you don’t have an answer to this question, find a coach, confidant or colleague and ask them.


I think it’s imperative, even an obligation, for leaders to tell their stories and share thoughts and ideas. To be in front of a situation and become the manifestation of the project. Sitting behind a desk, shooting off emails, creating agendas and barking orders only perpetuates mistrust and misunderstanding. Ultimately, this not only hurts the leader, the company and followers.


To the leaders in our industry: we need you. We are looking for your guidance. We are ready, willing, and extremely capable of executing the tasks that support our professional and personal goals. Through the process of leadership excellence, we will feel that we are part of the team, that we belong, are taken care of, matter and that we serve a higher purpose.


Today, right now, take one step to dispel any of the indicators of poor leadership mentioned above. Even if you are the best leader on the planet with stellar feedback, what is one thing you can do to improve? And importantly, what do you want your legacy to be? ●


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