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Clinical Project Manager:
Leading Causes of Problem-Solving
Inefficiencies
Introduction
A Clinical Project Manager (CPM) job is a high-rank position in the
research world that many CRAs and investigators are aiming to reach.
Being a Clinical Project Manager entails careful thinking, planning, and managing
all features of a trial or study.
The CPM’s role is to act as a middleman between
the sponsor and the site.
This means that he or she will be responsible for managing and leading CRAs and
other site medical specialists such as PIs, sub-investigators, nurses, coordinators,
etc.
2
PAGE 3
© 2016 Planner-Template All rights reserved
In order to be a successful Clinical Project Manager, one should possess all of the following skill sets:
What Skills Should a CPM possess?
CPM Skill Sets
Project management
methodologies
Problem-solving
capabilities
Analytical SkillsGreat communication
skills
Leadership Abilities
1 2 3 4 5
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© 2016 Planner-Template All rights reserved
In order to be a successful Clinical Project Manager, one should possess all of the following skill sets:
What Skills Should a CPM possess?
CPM Skill Sets
Financial knowledge in
studies and trials
Able to evaluate and
resolve issues
Critical thinkingKnowledge of protocols
and training site staff
1 2 3 4
5
What are the leading causes of
problem-solving inefficiencies?
As a Clinical Project Manager, you’ll be constantly surrounded by people
and teams. Your problem-solving abilities are crucial for taking care of
issues. However, most CPMs have reported various common problems
that can lead to problem-solving disruptions.
Some of the most important problems that should be avoided or resolved
can be found in the next few slides.
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© 2016 Planner-Template All rights reserved
Miscommunication Among the Team
Often, a CPM will have to lead studies with large
protocols that might even require over one hundred
CRAs.
Because of the fact that there are so many CRAs
under one CPM’s guidance, it can sometimes be
difficult to establish good communication lines
between all of you.
This is one of the biggest problems that CPMs
experience. Miscommunication or lack of
communication in a team can lead to many
confusions and unnecessary time and resources
wasted.
PAGE 7
© 2016 Planner-Template All rights reserved
Miscommunication Among the Team
In order to improve the communication process between
team members, you can try dividing the CRAs into groups
according to different criteria such as regions, sites, etc.
Like this, the CRA groups can discuss their weak points
among each other and then they can communicate these
points and items to other CRA groups.
For you as a Clinical Project Manager, what’s important in
this area is to make sure that busy sites which work with a
lot of patients have enough CRAs. When you don’t have
enough CRA coverage, many site issues remain unresolved
and problems start piling up.
This is why the CPM’s job is so important – to make sure
that all processes run smoothly, all sites are covered with
enough CRAs, and CRAs aren’t overworked. Careful
planning and allocation of resources are two of the best
traits that a CPM can have!
Divide CRAs into groups!
PAGE 8
© 2016 Planner-Template All rights reserved
Insufficient Expertise and Proficiency
The second biggest problem that almost all Clinical Project Managers
encounter is connected to unprofessional CRAs who aren’t able to do
their job properly. If a CRA is not familiar with the protocol and doesn’t
resolve site problems, you will be the person held responsible for it. So
eventually, you would either have to do the CRA’s tasks yourself, or
retrain the CRAs that need more expertise. Of course, in the long run, it’s
best if you retrain all your CRAs to make sure that all of them know the
protocol and are familiar with the therapeutic indication of their
respective sites.
Another option would be to hire a registered nurse or a medical
monitor and give them the task to train all CRAs (or the ones who
need training) in the protocol and therapeutic indication. Another
thing that you can do together with the CRO is to pull all the data
from risk-based monitoring and help your CRAs by pointing out
sites that fail to report adverse events or the most commonly
noticed adverse events. Like this, they’ll have a better overview
of things and will be able to their job better.
PAGE 9
© 2016 Planner-Template All rights reserved
Insufficient Resources
Finally, the last issue that most Project
Managers will face at some point is the lack of
resources necessary for a well-organized and
productive workflow. Unfortunately, CROs are
starting to become more and more resistant
towards the idea to hire more CRAs when
necessary.
Instead, they’ve decided to implement the so-
called Risk-Based monitoring instead of the
Traditional monitoring which requires 100% SDV
(source data verification).
The reason for this is because traditional
monitoring would require more CRA time on the
site in order to do a complete SDV, while risk-
based monitoring focuses only on the risk
profiles and weak points of each site.
The purpose of this new type of monitoring is to
become more effective and efficient, and to
dismiss the need of hiring more CRAs. After all,
CROs are also working for a profit.
With this recent change, the SDV task now
belongs to the site itself. So, unfortunately,
resources can be a problem in clinical trials but
there’s not much you, as a Project Manager, can
do to change that.
The best thing you can do in a situation like this
is to use all the resources you have available in
the smartest and most strategic way possible.
For example, use site staff that’s already there
and try to give them some of the tasks. Do the
best with what you have!
www.trialjoin.com
CONCLUSION
A Clinical Project Manager has many responsibilities on his/her shoulders. Aside from this, sometimes they experience obstacles that
aren’t in their control. Regardless, a CPM should be able to do the best with what’s provided and to effectively work with a large group
of people. As we’ve mentioned above, some of the most common inefficiencies that a Project Manager will experience are in the field of
communication, expertise, and resources. In other words, miscommunication or lack of communication, insufficient expertise and
professionalism of team members (CRAs), and lack of resources.
All of these problems should be resolved with careful thinking, good communication channels, CRA training, and strategic allocation of
resources. A good CPM will have amazing problem-solving skills, leadership skills, expertise and experience which will allow him/her to
overcome these barriers.
10

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Clinical Project Manager: Leading Causes of Problem Solving Inefficiencies

  • 1. Clinical Project Manager: Leading Causes of Problem-Solving Inefficiencies
  • 2. Introduction A Clinical Project Manager (CPM) job is a high-rank position in the research world that many CRAs and investigators are aiming to reach. Being a Clinical Project Manager entails careful thinking, planning, and managing all features of a trial or study. The CPM’s role is to act as a middleman between the sponsor and the site. This means that he or she will be responsible for managing and leading CRAs and other site medical specialists such as PIs, sub-investigators, nurses, coordinators, etc. 2
  • 3. PAGE 3 © 2016 Planner-Template All rights reserved In order to be a successful Clinical Project Manager, one should possess all of the following skill sets: What Skills Should a CPM possess? CPM Skill Sets Project management methodologies Problem-solving capabilities Analytical SkillsGreat communication skills Leadership Abilities 1 2 3 4 5
  • 4. PAGE 4 © 2016 Planner-Template All rights reserved In order to be a successful Clinical Project Manager, one should possess all of the following skill sets: What Skills Should a CPM possess? CPM Skill Sets Financial knowledge in studies and trials Able to evaluate and resolve issues Critical thinkingKnowledge of protocols and training site staff 1 2 3 4
  • 5. 5 What are the leading causes of problem-solving inefficiencies? As a Clinical Project Manager, you’ll be constantly surrounded by people and teams. Your problem-solving abilities are crucial for taking care of issues. However, most CPMs have reported various common problems that can lead to problem-solving disruptions. Some of the most important problems that should be avoided or resolved can be found in the next few slides.
  • 6. PAGE 6 © 2016 Planner-Template All rights reserved Miscommunication Among the Team Often, a CPM will have to lead studies with large protocols that might even require over one hundred CRAs. Because of the fact that there are so many CRAs under one CPM’s guidance, it can sometimes be difficult to establish good communication lines between all of you. This is one of the biggest problems that CPMs experience. Miscommunication or lack of communication in a team can lead to many confusions and unnecessary time and resources wasted.
  • 7. PAGE 7 © 2016 Planner-Template All rights reserved Miscommunication Among the Team In order to improve the communication process between team members, you can try dividing the CRAs into groups according to different criteria such as regions, sites, etc. Like this, the CRA groups can discuss their weak points among each other and then they can communicate these points and items to other CRA groups. For you as a Clinical Project Manager, what’s important in this area is to make sure that busy sites which work with a lot of patients have enough CRAs. When you don’t have enough CRA coverage, many site issues remain unresolved and problems start piling up. This is why the CPM’s job is so important – to make sure that all processes run smoothly, all sites are covered with enough CRAs, and CRAs aren’t overworked. Careful planning and allocation of resources are two of the best traits that a CPM can have! Divide CRAs into groups!
  • 8. PAGE 8 © 2016 Planner-Template All rights reserved Insufficient Expertise and Proficiency The second biggest problem that almost all Clinical Project Managers encounter is connected to unprofessional CRAs who aren’t able to do their job properly. If a CRA is not familiar with the protocol and doesn’t resolve site problems, you will be the person held responsible for it. So eventually, you would either have to do the CRA’s tasks yourself, or retrain the CRAs that need more expertise. Of course, in the long run, it’s best if you retrain all your CRAs to make sure that all of them know the protocol and are familiar with the therapeutic indication of their respective sites. Another option would be to hire a registered nurse or a medical monitor and give them the task to train all CRAs (or the ones who need training) in the protocol and therapeutic indication. Another thing that you can do together with the CRO is to pull all the data from risk-based monitoring and help your CRAs by pointing out sites that fail to report adverse events or the most commonly noticed adverse events. Like this, they’ll have a better overview of things and will be able to their job better.
  • 9. PAGE 9 © 2016 Planner-Template All rights reserved Insufficient Resources Finally, the last issue that most Project Managers will face at some point is the lack of resources necessary for a well-organized and productive workflow. Unfortunately, CROs are starting to become more and more resistant towards the idea to hire more CRAs when necessary. Instead, they’ve decided to implement the so- called Risk-Based monitoring instead of the Traditional monitoring which requires 100% SDV (source data verification). The reason for this is because traditional monitoring would require more CRA time on the site in order to do a complete SDV, while risk- based monitoring focuses only on the risk profiles and weak points of each site. The purpose of this new type of monitoring is to become more effective and efficient, and to dismiss the need of hiring more CRAs. After all, CROs are also working for a profit. With this recent change, the SDV task now belongs to the site itself. So, unfortunately, resources can be a problem in clinical trials but there’s not much you, as a Project Manager, can do to change that. The best thing you can do in a situation like this is to use all the resources you have available in the smartest and most strategic way possible. For example, use site staff that’s already there and try to give them some of the tasks. Do the best with what you have!
  • 10. www.trialjoin.com CONCLUSION A Clinical Project Manager has many responsibilities on his/her shoulders. Aside from this, sometimes they experience obstacles that aren’t in their control. Regardless, a CPM should be able to do the best with what’s provided and to effectively work with a large group of people. As we’ve mentioned above, some of the most common inefficiencies that a Project Manager will experience are in the field of communication, expertise, and resources. In other words, miscommunication or lack of communication, insufficient expertise and professionalism of team members (CRAs), and lack of resources. All of these problems should be resolved with careful thinking, good communication channels, CRA training, and strategic allocation of resources. A good CPM will have amazing problem-solving skills, leadership skills, expertise and experience which will allow him/her to overcome these barriers. 10