Project Management

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Topics: Healthcare, Pharmaceutical
Project Management in Clinical Research
Are there opportunities out there to volunteer in Clinical Project Management? I would like to volunteer in this area to gain a broader understanding of how this PM field is managed. Possibly learn some new skills in how those projects are handled in comparison to the ones I presently work.
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William -

You may want to start by finding someone within your local PMI chapter who works in that industry and would be willing to speak to you about the unique challenges, life cycle approaches and so on.

Kiron
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1 reply by KWIYUH MICHAEL WEPNGONG
Dec 14, 2020 9:55 AM
KWIYUH MICHAEL WEPNGONG
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Local chapter is key if you are registered with one, Thanks Kiron
I agree with Kiron. You better start in your local Chapter
Well, maybe if you contact Mayo Clinic ...
They are a non-profit org and accept volunteers, maybe also for PM.
They also have a great PMO.

And look here to whom you might want to connect:
https://www.pmi.org/about/leadership-gover.../teresa-knudson
Start with your local chapter. There aren't widely available volunteer positions and due to all the requirements of training if you don't already have experence, it's hard to break in.
Dec 03, 2020 8:13 AM
Replying to Kiron Bondale
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William -

You may want to start by finding someone within your local PMI chapter who works in that industry and would be willing to speak to you about the unique challenges, life cycle approaches and so on.

Kiron
Local chapter is key if you are registered with one, Thanks Kiron
William - do you have any experience in drug development or regulations about it? If no, the first thing I'd say to do is learn GCP (good clinical practice) because per the regulations of this industry you can't work on something you're not trained to do.

Also, there's typically a progression in clinical project management that's outside the norm. Typically to be a clinical PM one has to have experience working on trials FIRST before getting the clinical job. The most common way is to work as a Clinical Research Associate (CRA) but there's also ways to get in working as a Lead DM, study associate, etc.

As it's a very competitive and regulated industry there's very few ways to "volunteer". You might be able to shadow someone to learn more but you'd have to reach out through your local chapter and might have more luck going through a clinical research organization such Association of Clinical Research Professionals (ACRP) or Society for Clinical Research Associates (SoCRA). I'd join one of these organizations immediately if you're not already a member as this will give you a chance to learn more about this field from the people doing it.

I spent over a decade in clinical research and now work in clinical software solutions so I'm happy to answer any questions
In Pharma industry, normally the project manager who handles the end to end product development takes care of the Clinical research which is one part of the overall project.

In few companies, there is a specific position who handles multiple products' clinical research being a special skill set requirement.

I am fully aligned with Susan's thoughts on this regarding capability development along with PM skill set.
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1 reply by Susan Marangos
Dec 23, 2020 6:46 PM
Susan Marangos
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In my experience - to get to be the PM who oversees everything for a drug (aka the whole submission package) takes a LOT of experience and often an advanced science or medical degree. (Not necessarily required but many have it.), it also usually requires some clinical research experience (typically at the study level as a CRA).

Considering that most drug development programs are in the actual billions - they're not going to put just any PM in charge of it. Even to be the manager for ONE study in the program usually requires a lot of knowledge and experience.

To the OP: go learn Good Clinical Practices (GCP) - you should be able to find a course online.
Dec 21, 2020 12:04 AM
Replying to Ganesh Manivannan
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In Pharma industry, normally the project manager who handles the end to end product development takes care of the Clinical research which is one part of the overall project.

In few companies, there is a specific position who handles multiple products' clinical research being a special skill set requirement.

I am fully aligned with Susan's thoughts on this regarding capability development along with PM skill set.
In my experience - to get to be the PM who oversees everything for a drug (aka the whole submission package) takes a LOT of experience and often an advanced science or medical degree. (Not necessarily required but many have it.), it also usually requires some clinical research experience (typically at the study level as a CRA).

Considering that most drug development programs are in the actual billions - they're not going to put just any PM in charge of it. Even to be the manager for ONE study in the program usually requires a lot of knowledge and experience.

To the OP: go learn Good Clinical Practices (GCP) - you should be able to find a course online.
Anonymous
Hello,
I am MSc student in Project Management. Currently I am doing on my thesis work. I have BSc degree in Public health educational background. I have been working in TB research unit project (clinical research) .My current job position is 'Field Research Coordinator'. I want to continue in project management in health care/Research& Development. Would you please recommend me any additional trainings should I take ? So far I revived GCP (Good Clinical Practice) and Research Ethics trainings and certified. Thanks

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