Tag: TMF
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25 Tips for Risk-Based Approaches to TMF Management
Written by Nicole M. Palmer In a time where new and amazing things are being invented every day, there’s an important change happening in the world of scientific experiments, a change that asks us to think differently about how we manage Trial Master Files (TMF). I see this as a chance to make the process much smoother…
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Redefining TMF Training
Written by Nicole M. Palmer & John R. Nocero How many times do we just do our homework quickly to get it done, without really learning and understanding it all the way? It’s kind of the same with training in the trial master file. Have you ever heard the phrase, “Where there is smoke, there is…
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Are you a TMF Hero or a Villian?
You either become a TMF hero or stay employed long enough to see yourself become the villain of compliance. Let me share a cautionary tale about my journey with the Trial Master File. In 2020, I joined a clinical trial team and quickly became the go-to person for managing the Trial Master File. From the…
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Recruiting Trial Master File Professionals: Essential Qualities and How to Stand Out
Recruiting the right Trial Master File professional is crucial for ensuring the smooth management of clinical trials. These individuals play a vital role in maintaining organized and compliant trial documentation, safeguarding data integrity, and supporting efficient regulatory submissions. In this blog, we will explore what qualities recruiters and hiring managers look for when recruiting TMF…
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The Importance of Researching Specific Roles in the Trial Master File for Your Career
Written by Nicole M. Palmer and John R. Nocero When you are considering a career in the clinical research industry or looking to make a career shift it’s crucial to research and dive deep on the various roles available within the Trial Master File (TMF) to find your perfect fit. The TMF is an essential…
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Unleashing the Power of Decentralization in Trial Master File Talent Acquisition
Greetings, Forward-thinking TMF Professionals! Welcome to the latest edition of Granular Level, your trusted source for all things related to the world of Trial Master File (TMF). In this issue, we explore the correlation between decentralized clinical trials and how employers should embrace decentralization when hiring TMF candidates. The Rise of Decentralized Clinical Trials Decentralized…
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Why Internal TMF Mock Inspections are Essential for Clinical Trial Success
Today, I want to talk about something that’s crucial for anyone working in the clinical research industry – the importance of conducting internal Trial Master File (TMF) mock inspections. For those of you who may not be familiar with the term, the TMF is a collection of essential documents that provides a complete history of…
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Inside a TMF Mind
By Nicole M. Palmer and John R. Nocero Motivation and personal development help people achieve their goals and become successful. Learning how to cultivate a positive and organized mindset when it comes to maintaining a Trial Master File is essential to ensure you are giving your best. The TMF is a very valuable piece for…
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I Love the TMF: Your Guide to Staying Organized
Written by Nicole M. Palmer As a professional in the clinical research industry, you understand the importance of maintaining a well-organized TMF. It is the backbone of any clinical trial and contains all the documentation necessary to support the study’s conduct, from start to finish. But, with all the documents, processes, and stakeholders involved, staying…