I'm the founder of the Clinical Trial Podcast, a podcast and blog platform for clinical research professionals. My goal is to interview leading experts in clinical trial management to help you accelerate your career and be a more effective leader. I enjoy connecting like-minded people, introducing new ideas, and immersing myself in an environment of continuous learning. I invite you to sign up for my weekly newsletter where I share useful and important clinical trail related insights.
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Postmarket Surveillance Studies, Research Revolution 2024, and more....
Published 12 months ago • 3 min read
In light of the EU Medical Device Regulation (MDR), medical device manufacturers are required to implement a Postmarket Surveillance (PMS) plan, which in turn may require them to conduct Postmarket Surveillance Studies.
To learn about Postmarket Surveillance Studies regulatory requirements, process for collecting clinical data for such studies, key elements of PMS plan, and more, I invited Dr. David Rutledge on the podcast.
David is the President & CEO at Global Strategic Solutions, where he works as a global consultant for clinical evaluations, clinical risk management, regulatory, quality, and clinical investigations.
He brings over 25 years of experience and knowledge in product-level analysis, clinical protocol and case report form development, scientific data analysis, organizational design, integration of science with business needs, quality management systems, signal detection, global clinical evaluations, clinical risk management, and regulatory affairs.
As a former tenured Professor/Chairman in academia, IRB member and clinical investigator, he understands the role of a PI as a sponsor-investigator in clinical trials. He has published over 100 manuscripts.
What I love about David is that he brings a perfect mix of academic and industry experience to the table. As fun fact, David was also the very first guest on my show. You can check-out my first interview with David here.
David is Six Sigma and CAPA certified, an ISO 13485 lead auditor, the author of Mythical Medical™: Revelations from a Global Product Approval Consultant.
P.S. I also started a YouTube channel. I'm trying to get to 1000 subscribers by September 30, 2024. Can you help me by subscribing to the Clinical Trial Podcast on YouTube?
This podcast is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit https://www.calyx.ai/
This podcast is brought to you by Florence Healthcare. Florence eliminates chaotic workflows in clinical research operations with remote access and digital workflow platforms. More than 18,000 study sites, sponsors, and CROs in 55 countries trust them to accelerate their operations. To learn more, visit https://florencehc.com
Florence Healthcare is hosting a site enablement conference that explores how technology links sponsors and sites to revolutionize research.
Research Revolution is one of the top clinical trial conferences where you can network with like-minded individuals who believe in a site-first approach and leverage technology to accelerate research.
The Second Mountain: The Quest for a Moral Life by David Brooks (Amazon, B&N)
Everybody tells you to live for a cause larger than yourself, but how exactly do you do it? This book explores what it takes to lead a meaningful life in a self-centered world.
When I was a Clinical Project Manager I, I remember thinking that once I'm a Clinical Project Manager III, I'll have my dream job and met my career goals.
But the goal post kept moving. Then I wanted to be a Manager, Senior Manager, Director,... You get the idea here.
When we're early in our career, we're chasing after a comfortable home, nice vacation, getting external validation from family and friends that "We've made it.". This is The First Mountain.
The "Second Mountain" is when we feel that the purpose of life is more than personal satisfaction and happiness. It's thinking about how we can be of service to others.
This is a great book if you're looking to find deeper meaning in your life.
Career Opportunities
The following organizations are hiring for clinical and non-clinical roles. If you’re interested in advancing your career & meet most of the job requirements, consider applying for the role.
Mercy Research in St. Louis, MO, is hiring for research roles.
Abbott Labs is hiring several roles in Research and Development which includes positions in Clinical Operations, Regulatory Affairs, Clinical Affairs, Medical Affairs, and more. I was an Abbott employee for close to 13 years and loved working for them.
I hear a lot of negative news about layoffs or being underpaid. But I'll tell you that there are many opportunities out there that are waiting for you. Permit yourself to seize the opportunities that align best with your skills and interests.
Hey friend! Thanks for listening to the Clinical Trial Podcast and subscribing to my blog. You are the best part of my clinical research journey and I appreciate you! As always, I'm here to help you accelerate your clinical research career. Till next time, Kunal "grateful" Sampat
Have a Question? I will try my best to answer it on the show.
I'm the founder of the Clinical Trial Podcast, a podcast and blog platform for clinical research professionals. My goal is to interview leading experts in clinical trial management to help you accelerate your career and be a more effective leader. I enjoy connecting like-minded people, introducing new ideas, and immersing myself in an environment of continuous learning. I invite you to sign up for my weekly newsletter where I share useful and important clinical trail related insights.
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