PowerPoint Presentation
Module 1
Getting Oriented to Clinical Research Project Management
CRM 761
Beth Loots, MPH MSW
Course Overview
Description, aims, objectives
Course description
This course will provide professionals with expertise in project management, as project-based work continues to proliferate both in scale and complexity, with organizations and clients demanding greater efficiency, outcomes, and proficiency. This cu
icula is designed to take participants through the entire life-cycle of a project.
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Course level outcomes
Upon completion of this course, the student will be able to:
Define a clinical trial using standard project management processes and technologies,
Integrate core project management principles and processes for effective clinical research management.
Evaluate how elements of cultural competency, project management and meeting management improve the performance of culturally diverse, multi-disciplinary teams.
Select among various team building approaches to build an effective team.
Assess organizational, cultural and personnel factors that influence successful clinical research performance.
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Approaching the course aims
Use academic evidence and real life examples and discussion
Touch on key points such as project management principles, organizational factors, project planning processes and tools, cross cultural work, and interdisciplinary teams
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Key outcomes I have in mind
Developing or expanding your knowledge and skills around what it might take to successfully plan and implement clinical research studies
Learning to skillfully lead and manage people and teams is key, so we will spend quite a bit of time on that
I will share ideas and experiences with the process of managing studies and some tools you can use for that
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PM skills
30% research knowledge and technical skills
70% communication skills
Richardson B. & Newman RW. Clinical trial management - an integrated process. Drug development; 2006.
A few words about lingo
Different terms seem to be used throughout the literature:Â Clinical Research Project Manager, Clinical Trial Manager, Project manager, Research Manager, Clinical Research Coordinator*, etc.
*Project managers may manage Clinical Research Coordinators (CRC) (which also go by many names), and/or they themselves may be a CRC or fulfill some of the coordination roles of a CRC. In my mind a CRC is more focused on implementation of the study, whereas a PM is focused on leading the overall project planning and implementation. That is not to say that a PM does not get involved in the day to day running of the study – they can and should do that to some extent.
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A few words about lingo
I've decided to generally use the term "Project Management" or "Clinical Research Project Management" in this course
The important part is not so much the title as is the function of this person on the team which is to help the PI lead the study to success
Course roles and responsibilities – meÂ
I aim to operate from a strengths-based model, meaning I value the skills, experiences, and perspectives that each person
ings to the table
By the way this is also how I do project management – often asking team members questions to get input and move processes forward in a more informed way
I will aim to work in collaboration with you to support your learning goals
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Course roles and responsibilities – you
I hope that you will find the course interesting and I trust that you will be engaged
Please give me feedback and ask questions as we go. My goal is to continuously learn and improve based on your important input.
PDCA (Plan Do Check Act)
I am available for questions and concerns so please contact me when needed
Course textbook and readings
Martien, N. & Nelligan, J XXXXXXXXXXThe Sourcebook for Clinical Research. Elsevier, Inc.: United Kingdom.
This book is aimed at providing a roadmap to research teams navigating clinical trials and clinic research more generally
There is an accompanying online resource of templates, forms, and checklists available
I've chosen a few other readings to supplement the text and the slides
Assignments
Power point from me every week
There will be a course-long research paper, which I have separated into chunks each week
The discussion board will also be due every week
I have provided additional videos and extra readings alongside text book readings each week
Lay of the Land
Some of the realities faced day to day
What usually happens when you start
You might start a single study right at the beginning as the PM...more likely, you will join an existing team which has a number of studies at various stages.
"The life of a researcher is...managing and implementing a portfolio of different projects on an ongoing basis."
You will likely be navigating different projects that are in different stages at the same time such as scientific development with investigators and other collaborators, operational setup, logistics of running various trials, database management, people management, and others
Often underfunded and understaffed
Often you will be stretched in multiple different directions at same time
Lund Pedersen, C. 23 January 202. This simple tool can help you manage multiple research projects: how to master the art of prioritization. Nature Index. https:
www.natureindex.com/news-blog/simple-tool-can-help-manage-multiple-research-science-projects
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Key things to think about re: your role
Your job as the PM will be to quickly get on board; assess the division, investigator, and studies' priorities and timelines; and move many projects forward on multiple fronts simultaneously
Very important to know how to manage people and teams
Need to know how to navigate the specific institution in which you work
You are the hub for assessing resources and priorities, and moving projects forward
Some parameters around what you need to be skilled at
You may be expected to be a content expert in research processes, particularly IRB, regulatory, and working with sponsors, since PIs tend to rely on PMs for this aspect of the work
Skills that you probably already have such as planning, prioritizing, multitasking, and communication are vital to a project manager's success. You can work to continuously improve these skills.
PMs don't tend to be the experts on the science – that is usually the role of the PI. That said, the PM should be somewhat familiar with the content area and with the patient/family focus of clinical research
You will also be expected to manage the activities of people on your team. This is not a small feat. People management takes time, attention, and skills
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Realities
Gets complex fast
Things almost never go as planned
Usually hidden (and sometimes competing) agendas that you only discover once you start doing the work.
You need to interact with others whom have different timelines and priorities than yours for things like grants and contracts, institutional approvals, IRB approvals, other committee reviews, IND applications, supplies, etc.
Your primary objectives – successful planning, startup, execution, and closeout of clinical studies – may not match the objectives of others with whom you need to collaborate
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Keeping the ship from veering off course
Your clinical investigator themselves will have multiple other competing priorities, and varying levels of skills managing people and projects
Often your project veers off course in terms of time or resources
There are many things that you will learn along the way such as not knowing exactly whom to contact for what, what hoops need to be jumped through, and what pieces are missing that you later discove
Continuously navigate towards the goals and objectives you are aiming to accomplish
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Real life examples
I've been in a few positions where I jumped into fires right from the start
Things like – deadlines already missed for IRB renewals, personnel and team problems that hadn't been dealt with, lack of resources (no pens, desks, chairs, or computers!), absence of standard procedures, no project plan, people working at cross purposes or duplicating work, te
ible communication, key priorities not addressed, etc.
That's often how it is...your role as PM is often to establish structure where it's lacking
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Jumping in
Hopefully this course will provide you with some tools and some ways to think about how to establish this structure and lead projects to success
Even with the best laid plans, clinical research throws curve balls A LOT
And...that's kind of what makes it interesting, if you can learn how to navigate it.
Part of the PM role is learning to identify what really is a fire and what is just being treated like one. Defining your own and your team's priorities within the larger context of what you are hoping to accomplish is key.
Your "why"
I would encourage you to reflect on why you are interested in being part of clinical research
Sometimes people have personal or family experiences with medical care or clinical research that drive them towards this field
Many appreciate the scientific and medical advancements that can be supported through great project management
It can be a great fit for people who enjoy both the organizational/project/logical part of it and the sometimes more nebulous team/people part
There can be a good career opportunity because there aren't a lot of people with specific skills in clinical research project management. Often you see people who have either clinical research experience or project management experience but not both.