Global Research Pharma Canada

Secrets for the Highly Effective Clinical Research Project Manager

It feels good when you can share your experience and knowledge to help other professionals in the same arena improve their own skills. Much more is the anticipation when that improvement can be easily translated to success and savings for your company (win/win).

First, let me define what a Highly Effective Project Manager is. He/she is the person responsible of the entire oversight of the clinical trial project and its proper implementation on time and within the budget (taking into account that the timeliness and the budget were properly established in the first place). To be considered a highly effective clinical research project manager, your experience in the clinical research enterprise has to be vast and real. I consider that anything less than 5 years of hands on monitoring experience at different levels, would not allow you to gasp all the variables in function of the real potential issues that may arise and hinder the success of your company project.

The Highly Effective Project Manager builds effectiveness around time and money in function of the desired outcome

Remember, the keywords on this conversation are "on time" and "within budget".

I highlighted two key issues that are the main factors in project failures (time and money). The highly effective project manager builds effectiveness around them.

Secret #1: BECAME AWARE - Reduce the unknowns to the minimum during the planning process, and include the higher risk due to new unknowns as a variable in the calculation of timelines and budget.

As a Clinical Research Project Manager, you should be extremely cautious in the planning process, especially if you are assigned to run clinical trials in new indications or with very innovative products where not only you, but nobody has experience.

Secret #2: BE REAL - Making/breaking point analysis with estimation of most realistic plan

Do not try to impress your director/superiors by underestimating budgets and planning very tight timelines and limited resources. As well as, do not overestimate timelines, budget and resources just “to be in the safe side”.

Unfortunately, in clinical research, some rules are different than in any other industry. Mainly, there is a limit on how much money and resources you can put in a project with the aim at reducing time to completion and increase the probability of success. (The limiting factor is that we are depending on human physiology and pathology to measure response, and that will follow the rules of nature). Therefore, we have what I call a the “breaking point” in project planning in which regardless of resources and money, we reach a plateau in the outcome.

Also, I established something I call a “making point” in project planning in which there is a minimum of budget resources and estimated time to completion that you could achieve. We can calculate the making point utilizing the critical path analysis, we can review the calculations to optimize them further. That is an ideal plan (with cost, resources, and timelines) that seldom exist in the real world, however it is good to have the idea for analysis and planning purposes.

A wise decision between the making and the breaking points (that include critical variables as is cost, timelines and resources, as well as include all the unknowns and the higher risks) should be made by the highly effective manager to bring the project to success. In this case, that decision will not be the result of application of another project management tools, as for instance is PERT and consider yourself happy. But to rationalize as well as incorporate many more variables and factors from real experience (not assumptions) provided by more observers and collaborators in the planning (see the secret #3)

Secret #3: LISTEN and LEARN- Discuss your project plan with the team and other managers, and include feedback before running into problems

Present your project plan to your team and other project managers that may be more experienced, and include everyone that has a critical task assigned to provide their feedback on the feasibility of the project. The latter are the ones implementing your project plan, and they may have a different approach to the tasks and timelines. A highly effective project manager listens to their team and peers, and values their contribution.

Of course, I have hundreds of tips and recommendations, and I can go on all day. However, I consider these three secrets key in the planning phase of a project. With accurate planning, and proper ongoing reevaluation, there is no need to incur in cost overruns and jeopardize and entire study or the development of a new drug.

I look forward to your feedback and experiences.

About the author: Dr. Vera M Madzarevic has more than 25 years of industry and academic experience and has dedicated her entire life on developing safe drugs. She is the Director of Research and Development of Global Research Pharma Canada and the Clinical Research Institute of America. She conducts GCP (Good Clinical Practices ) audits in compliance with FDA, Health Canada and EMA, as well as conducts clinical trials worldwide. She also educates medical and scientific professionals on clinical research and drug development. She is a published author.

Dr. Madzarevic is a published author, if you want to peruse inside Vera's book on drug safety, it is available at here