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Management Consulting for Clinical Research

Managing in Complex Research Organizations

Consensus is a false god and a time sink.

 

We all work in increasingly complex research communities, and it is not getting any easier to get things done, despite heightened urgency, potentially plentiful resources, exciting scientific advancements and loads of talented people. Middle and senior managers are tasked with moving their organizations to get things done – faster, cheaper, and always with uncompromised quality.

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If only it was as simple as this diagram suggests!

 

 

 

 

 

 

Complex to Simple

Complexity, by its nature, takes many forms. From a management perspective, complexity is contributed by upper management pressures, responsibilities to your staff, the uncertainties of clinical research itself, the unknowns we are trying to discover and then overcome, and the interdepartmental, inter-company collaboration which is increasingly the norm.

The complexity you face is probably not your fault personally, but we do make it worse. We contribute to it by how we react to it, and how well (or not) we understand it. It is only going to become more common, so learning to embrace it, and to simplify it, will greatly benefit your organization and your career.

 

Histories and Personalities

Organizations have histories and personalities, strengths and fears, just like individuals do. This is so important to recognize, because just as we are influenced by how we handle things, and what has happened to use before, so do companies. Sometimes we call this “culture,” and too often our scientifically trained minds wander when we hear that. But in our increasingly interconnected and interdependent approach to Clinical Development, we are entwining histories and fears and personalities. For instance:

  • Your research partner had a 483 just last year, but you never have.
  • Your CRO is a big advocate for using the latest technology, but your company had bad experiences ten years ago.
  • The little biotech you bought has been obligated to work fast, decide fast, and can’t afford to think about it, but your value is in your maturity and experience to inform and evaluate their thinking.
  • Your research partner has dozens of products to develop, manufacture and sell, but your whole world is this one candidate you brought painfully into the clinic.
  • Your CRO’s business model is completely different from yours, and this is compounded by four additional niche service providers who you need but don’t trust or understand.

Embracing & Understanding Complexity

 Our complex organizations and relationships in Clinical Development cry out for strong effective leadership – that’s you! That leadership you exhibit must embrace and understand the complexity. Understanding starts with:

  • What are the stated Key Business Drivers for the organization and how does your work demonstrably contribute to them?
  • What are the unwritten power relationships in your organization?
  • Who is doing what, when? – where are the overlaps in responsibility and accountability, and how may are they competing or contradictory?
  • Where’s the money and who controls it?
  • How can you exploit peer self-interests, instead of only being frustated by them? Can you understand their personal and departmental professional and financial incentives?

Don’t Just Cope, Simplify

 Complexity is Clinical Development has been sneaking up on us for decades, like the proverbial lobster slowly boiling in the pot. Since we all still have our “day job”, all we often have time for is coping:

  • Firefighting the day’s issues
  • Accepting compromise and suboptimal performance
  • Protecting core interests and budgets
  • “There’s always next year….”

But there is a more productive use of our time and skill – to recognize the complexity and actively seek to simplify it. For instance:

  • Overlapping accountabilities can be split up & apportioned for mutual benefit, so that everyone has a piece of success.
  • Look for the facts in a given situation, and leverage it to overcome political or personality obstacles.
  • Remind peers & superiors that you all have common purposes.
  • Exploit power discrepancies appropriately because you are in the best position to recognize how to appeal to all points on the circle.
  • Most importantly, seek commonalities rather than

Consensus is a false god and a time sink. We use it because we think it leads to political correctness, as if that was key to productivity or efficiency or progress. It is not important to sit in a room until everyone agrees on something. But it isimportant that we get most people to recognize what they have in common, and how what they are going to do will serve that.

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“But It is Complex….”

Some readers, and/or some colleagues, may object to this approach thinking it is minimizing the technical, scientific, financial and interpersonal obstacles to Clinical Development today. This is understandable but doesn’t lead anywhere. Reassuring ourselves that our work is difficult is only slapping our egos on the back. Of course we need to ensure nothing important to patient safety, or colleague respect, or financial viability is tossed under the bus in our desire for simplicity. But there is a broad middle ground to operate in to improve our focus.

 

Focus Focus Focus

Having and maintaining focus is the key to managing in a complex organization and reaching your goals within it. Trim the to-do list, trim the cross-project links, trim the Inbox, and trim the promises you and your staff make to others. By focusing on agreed-upon priorities, and only those priorities, you can achieve a series of victories which will create progress, and positive momentum. You can create your own positive feedback loop.

If something is intractable, move on to a parallel shared point of focus. If something new looks more attractive, think long and hard about changing direction – can you finish something on your current work before switching and moving on? If you demonstrate you can be successful, more trust and virtual power will flow to you: most everyone wants the complexity simplified, unless they are hiding poor performance underneath it.

Your organization will be excited that progress is being made, and they will understand what and who was the catalyst. Be the catalyst that simplifies complexity, and everyone will reap the benefits.

 

 

 

 

 

 

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