PowerPoint Presentation Project Planning and Management in Clinical Research Project manager is responsible for 3 main things Manage project communications Monitor and manage project...

PowerPoint Presentation
Project Planning and Management in Clinical Research
Project manager is responsible for 3 main things
Manage project communications
Monitor and manage project progress
Budget management
"Webinar: The Role of the Project Manager in Research." (1:00:34) https:
www.youtube.com/watch?v=0J20SZ3rq7Q
Project planning and management
When done well, it can lead to successful clinical trials
Control scope, time, cost, and quality
Include risk assessment and risk management
Ensure system for communication is built into your plan
Outline clear decision-making roles and responsibilities
Start the project plan at the beginning of the study and include the entire scope of the protocol
Hosely, M. Project management & Planning for Successful Clinical Trials." September 1, 2020. And "Webinar: The Role of the Project Manager in Research." (1:00:34) https:
www.youtube.com/watch?v=0J20SZ3rq7Q 
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Project management plan variables
Take the grant proposal and/or protocol and translate it into a practical project plan
Think about what local SOPs may be needed to develop and ca
y out the research at your site
Talk through the details and the logistics of how your team will conduct the study
Determine how you will monitor the activities of your team in order to ensure timely and co
ect completion of activities
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Planning phase
What problem (or study aspect) needs to be solved?
Who will be involved?
What steps will be taken to solve the problem?
The problem presented to you to fix or do may not be the one that needs to be fixed – need to look at root causes
Very important to ask questions about what is needed, in order to develop solutions that actually fix the problem
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Project plan elements
Clear objective(s) stated – what 
Timelines for completion of various activities – who, how, and by when
Resources needed for the work – what and who
Accountability of people involved – who does what
Communication system planned - how
Risks assessed and planned for - what
Hosely, M. Project management & Planning for Successful Clinical Trials." September 1, 2020. and Fa
ell, B., Kenyon, S. & Shakur, H. Managing clinical trials. Trials 11, XXXXXXXXXXhtttps:
doi.org/10.1186/ XXXXXXXXXX
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Clear objectives around things like
Patient outcomes
Study outcomes
Investigator outcomes
Team process outcomes
...use SMART goals
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Scope of work
With research studies there is usually a general scope of work that outlines what the site is responsible for in terms of deliverables
However this document is usually a formality and not detailed enough
You should instead look at the protocol and determine the scope of what your teams needs to do
Determine scope
Many projects or studies take on too much and underestimate the resources needed
In my experience recruitment and coordinating efforts are notoriously underestimated
Can use something called Work Breakdown Structure (WBS) to try to get a more realistic idea of what is needed
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Work Breakdown Structure (WBS)
What will have to be done in order to get x done?
Keep asking that question until it is
oken down into tasks that cannot be subdivided furthe
Estimate how long each task will take – person hours to do
HBR Editors. The Four Phases of Project Management. November 3, 2016.
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Work Breakdown Structure example
Work Breakdown Structure example
Deliverables diagram
Gantt Chart
Project plan template
Timelines
Account for study startup time which can be lengthy
Deadlines for IRB and other review committees
Length of project and key deliverables
Enrollment windows
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Timeline example
Resources
Define your resources
What staff are needed to complete a protocol, or multiple protocols simultaneously as is more often the case
Where are the gaps – escalate and advocate for more
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Creating a schedule
Work backwards from drop-dead deadlines
What deliverables are due when
Who does what
Calculate task timelines
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Monitor and track project progress
"Watchtower"
What is happening with the study and are we meeting the goals or objectives that we need to be
Are our processes working as we think they should be
Making course or effort adjustments as needed
Monitoring project scope and making sure team members aren't being pulled away from their primary objectives and projects. Say no to things outside scope.
Sometimes the scope does change, but then need to re-negotiate efforts/time/quality on other activities in order to make this change
Budget management
Pre-award
Prepare the budget for the study
Make sure the budget covers the staff needed to accomplish activities
Post-award
Monitor expenditures on the study – purchases, staff time, patient costs
Spend per the funder and institutional requirements
Post-project
Prepare for audits
Close out the study
Key takeaways for project planning
Relationship and team building
Clear communication around project tasks and goals
Control project scope
Manage timelines
Adequate budget to do the work, and cost control
Adequate resources – people mainly
The goal is to control time and resources in order to accomplish scope in a high quality manner