TMF Daily

TMF Indexing

In this episode, Nicole will discuss:
 *What is TMF indexing?
 *Why is TMF indexing important?
*TMF Index Plan *Document numbers/codes
*Navigating and retrieving documents
*Tips and best practices
 
Our Sponsor: If you need help getting your foot in the door with clinical research and want to learn eTMF:
Granular Level: www.granularlevel.com You’re watching TMF Daily Podcast on YouTube, a place where you can learn and feel empowered about the Trial Master File. Welcome to the show. I’m your host, Nicole Palmer. On TMF Daily Podcast, we delve into all areas surrounding the TMF. Make sure to hit the ‘subscribe’ button, and don’t forget to click the bell icon.
Listen/Subscribe to TMF Daily:
Apple: https://podcasts.apple.com/us/podcast/tmf-daily/id1726037751
Spotify: https://open.spotify.com/show/0Pl9eqFpghzCwLJSSLgDAQ
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 Instagram: https://www.instagram.com/tmf_enthusiast/
Website: https://tmfdaily.podbean.com/
Apply for the eTMF Specialist course here:
https://granularlevel.com/education/ 
 Enjoy the show! #etmf #trialmasterfile #clinicalresearchcareers

TMF Job Market 2024

Dante Alducin is the Founder and CEO of Blast! Academy, a company dedicated to providing soft-skills training to professionals from the pharmaceutical industry. Blast offers personalized mentoring programs and customized courses for various
In 2021, Dante was awarded and named “top 100 Visionaries in Education.” For his exceptional contributions to the education industry.
In this episode Dante and Nicole will discuss:
-Challenges of the job market
-How to make your resume standout
-Skills that employers are really looking for
-Effective ways to network
-Strategies to overcome setbacks
 Make sure to hit the ‘subscribe’ button, and don’t forget to click the bell icon.
Listen/Subscribe to TMF Daily:
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Spotify: https://open.spotify.com/show/0Pl9eqFpghzCwLJSSLgDAQ
iHeartRadio: https://iheart.com/podcast/143516412
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Instagram: https://www.instagram.com/tmf_enthusiast/
Website: https://tmfdaily.podbean.com/
TMF Courses: https://granularlevel.com/education/
Enjoy the show!
#etmf #trialmasterfile #clinicalresearchcareers

History of the TMF Reference Model with Karen Roy

Get ready for an enlightening discussion on today's episode of the TMF Daily Podcast!
🌟 Joining us is Karen Roy, a trailblazing TMF expert and co-founder of the TMF Reference Model.
🔍 Together, we'll explore a multitude of topics, including:
Karen's journey to becoming an authority in TMF management
The transformative strengths of TMFs and their impact on the clinical research field
The pioneering steps toward establishing key eTMFs
The critical role of transparent communication in TMF documentation
The power of collaboration and risk-taking in advancing your TMF career
Exciting future trends shaping the TMF landscape
and more....
Karen Roy: https://www.linkedin.com/in/karenjroy/
CDISC TMF Forum: https://www.cdisc.org/new-to-cdisc/tmf-professional
2024 CDISC + TMF Europe Exchange April 24-25 Berlin: https://www.cdisc.org/events/interchange/2024-cdisc-tmf-europe-interchange
2023 CDSIC + TMF US Exchange October 23- 24 Arizona: https://www.cdisc.org/events/interchange/2024-cdisc-tmf-us-interchange
 
🌟🌟🌟🌟🌟🌟
You’re watching TMF Daily Podcast on Youtube, a place where you can Listen, Learn, and be Empowered. Welcome to the show. I’m your host, Nicole Palmer. On TMF Daily Podcast, we investigate a new TMF topic bi-weekly and interview some of the brightest minds in the world.
Make sure to hit the ‘subscribe’ button, and don’t forget to click the bell icon. ➡️ YouTube: https://www.youtube.com/@TMFDaily Enjoy the show!
#TMF #clinicalresearch

From CTA to SMO

In today's episode of TMF Daily, join us in a valuable exchange with the industry pioneer, Mitch Hilby. As he reveals behind-the-scenes insights on excelling in clinical trials and acing the Trial Master File (TMF) industry. Mitch shares his diverse experiences, from oncology to autoimmune diseases and women's health, promising to offer enriching insights for both seasoned professionals and newcomers to clinical research.
Discover Mitch's personal journey from being a Clinical Trial Assistant (CTA) to playing key roles in transformative clinical research processes. The episode emphasizes the importance of diligence, underscoring the critical role professionals play in the industry's advancement. Mitch reflects on his early professional years, praising the room for growth offered by intimate work experiences at small Clinical Research Organization (CRO).
Dive into the heart of this lively conversation where Mitch reveals the ins-and-outs of transitioning from a standard CRA role to a more immersive experience within company operations. The discussion pinpoints the advantages of setting a well-structured investigator site file, outlining the potential rewards of crafting site files that align with the DIA model for TMF.
Dive into the creation of 'Clinical Research Justice League', a concept designed to drive change by aligning industry stalwarts to tackle critical ethical issues in research. As the episode draws towards a climax, hear about the birth of Diversa Trials, a unique venture built on a shared vision of transforming the standard SMO model towards a more equitable approach to clinical research.
In this thought-provoking conversation, Mitch outlines the importance of team building, fostering an empathetic work culture, and managing intense responsibilities. He emphasizes the power of networking and offers valuable advice on forming and strengthening professional relationships. Join us for this enriching exploration of positivity, teamwork, and effective networking in the world of clinical research.
Mitch's LinkedIn: https://www.linkedin.com/in/mitchell-hilbe-a89147123/
DiversiTrial: https://diversitrials.com/
Our Sponsor:
If you need help getting your foot in the door with clinical research and want to learn eTMF Granular Level is your go to for all things TMF.
You're listening to TMF Daily Podcast, a place where you can learn and feel empowered about the Trial Master File. Welcome to the show, I'm your host, Nicole Palmer. On the TMF Daily Podcast, we delve into all areas surrounding the TMF.
Make sure to hit the 'subscribe' button, and don't forget to hit the bell icon.
Listen/subscribe to TMF Daily:
Apple: https://podcasts.apple.com/us/podcast/tmf-daily/id1726037751
Spotify: https://open.spotify.com/show/0Pl9eqFpghzCwLJSSLgDAQ
iHeartRadio: https://iheart.com/podcast/143516412
Follow me:
LinkedIn: https://www.linkedin.com/in/nicole-m-palmer-ms-7718b3201/
Instagram: https://www.instagram.com/tmf_enthusiast/
Website: https://tmfdaily.podbean.com/
Enjoy the show!
#etmf #trialmasterfile #clinicalresearchcareers

The Vital Role of an eTMF Specialist in Clinical Research

In this episode of the TMF Daily Podcast, your host Nicole Palmer delves into the importance and responsibility of an eTMF (Electronic Trial Master File) Specialist in clinical research. Responsible for overseeing the electronic trial master file system, eTMF Specialists play a crucial role in ensuring the completeness, accuracy, and compliance of trial documentation throughout a trial's life cycle.
One of their main tasks includes establishing and maintaining the structure of the eTMF, this includes creating folders, defining document types, and implementing naming conventions. eTMF Specialists also need to monitor the completeness and quality of trial documentation. They are the eyes and ears ensuring all documents are present and up to date. They also conduct regular reviews and identify discrepancies, working in tandem with study teams to address issues and ensure compliance with regulatory provisions.
With ongoing advancement in technology, eTMF specialists are also expected to keep a steady pace with technological developments and leverage technologies like Artificial Intelligence, Machine Learning, and Blockchain to enhance the capabilities of eTMF systems.
The job outlook for eTMF specialists looks promising. With pharmaceutical and biotech industries increasingly adopting ETMF systems to streamline their document management, the demand will continue to grow. Current trends in the industry include growing regulatory requirements around trials and the need for data precision. Hence, the outlook for eTMF specialists holds great promise with numerous opportunities on the horizon.
As for remuneration, the salary of an eTMF specialist can vary based on several factors such as geographic location, level of experience, organization size, and more. On average, in the United States, it could range anywhere from $50,000 to $80,000 a year. Entry-level ETMF specialists can expect earnings towards the lower end of the range, while those with years of experience or advanced certifications could command higher salaries.
The episode also outlines the potential career paths for an eTMF professional, varying from entry-level coordinators, eTMF specialists, senior eTMF specialists to managerial roles, and finally executive-level positions where the professionals take charge of shaping the organizational policies and procedures related to document management and regulatory compliance.
Listen in for a deep dive into a career as an eTMF specialist and the accelerating demand for this exciting and rewarding role in clinical research.
Our Sponsor:
If you need help getting your foot in the door with clinical research and want to learn eTMF: Granular Level: www.granularlevel.com
Make sure to hit the ‘subscribe’ button, and don’t forget to click the bell icon.
Listen/Subscribe to TMF Daily:
Apple: https://podcasts.apple.com/us/podcast/tmf-daily/id1726037751
Spotify: https://open.spotify.com/show/0Pl9eqFpghzCwLJSSLgDAQ
iHeartRadio: https://iheart.com/podcast/143516412
Follow me:
LinkedIn: https://www.linkedin.com/in/nicole-m-palmer-ms-7718b3201/
Instagram: https://www.instagram.com/tmf_enthusiast/
Website: https://tmfdaily.podbean.com/
Enjoy the show!
#etmf #trialmasterfile #clinicalresearchcareers
 
 
 
 
 
 

Inside a TMF Mind

In this episode, Nicole will discuss:
- Maintaining a TMF requires attention to detail, organization, and diligence.
- A positive mindset can help you approach the task with confidence, focus, and determination.
- How to cultivate a TMF mindset
- Set your intention
- Focus on what you can control
- Break it down
- Stay positive.
Our Sponsor:
If you need help getting your foot in the door with clinical research and want to learn eTMF: Granular Level: www.granularlevel.com
You’re watching TMF Daily Podcast on YouTube, a place where you can learn and feel empowered about the Trial Master File. Welcome to the show. I’m your host, Nicole Palmer. On TMF Daily Podcast, we delve into all areas surrounding the TMF.
 Make sure to hit the ‘subscribe’ button, and don’t forget to click the bell icon.
Listen/Subscribe to TMF Daily:
Apple: https://podcasts.apple.com/us/podcast/tmf-daily/id1726037751
Spotify: https://open.spotify.com/show/0Pl9eqFpghzCwLJSSLgDAQ
iHeartRadio: https://iheart.com/podcast/143516412
Follow me:
LinkedIn: https://www.linkedin.com/in/nicole-m-palmer-ms-7718b3201/
Instagram: https://www.instagram.com/tmf_enthusiast/
Website: https://tmfdaily.podbean.com/
Enjoy the show!
#etmf #trialmasterfile #clinicalresearchcareers

Find Your Why

John Nocero is the Director of Quality & Compliance at Segal Trials in Miami Lakes, Florida. He leads a 15-person quality crew, responsible for all things quality, regulatory, education training, and compliance. He has been blogging with me about clinical research on LinkedIn since 2017. He is inspired by the Irish Professional Wrestler, Becky Lynch, whose personal story centers on achievement, tenacity, grit, and overcoming adversity. She epitomizes being "The Man" in your own life and John is going, in his words, Becky Level, in 2024. 
In this episode, John and Nicole will discuss:
- How John started his career in clinical research
- Finding your why and keeping your eye on the tiger
- How quality and compliance efforts intersect with the management of the TMF
 
- The critical role quality plays in ensuring the integrity of the Trial Master File
 
-How maintaining quality and compliance directly impact the success of clinical trials, especially concerning the TMF
 
-Key strategies John implemented to ensure not just compliance but a culture of quality excellence within the clinical research industry
 
-What it means to reach “Becky Level”
 
-2024 Goals and themes
 
-How writing articles can create opportunities and a following on LinkedIn
 
-Advice John offers to those navigating the complexities of quality and compliance in the clinical research industry, particularly when it comes to the TMF
 
John’s LinkedIn: https://www.linkedin.com/in/johnrnocero/
 
Our Sponsor:
If you need help getting your foot in the door with clinical research and want to learn eTMF: Granular Level: www.granularlevel.com
You’re watching TMF Daily Podcast on YouTube, a place where you can learn and feel empowered about the Trial Master File. Welcome to the show. I’m your host, Nicole Palmer. On TMF Daily Podcast,  we delve into all areas surrounding the TMF.
 Make sure to hit the ‘subscribe’ button, and don’t forget to click the bell icon.
Listen/Subscribe to TMF Daily:
Apple:  https://podcasts.apple.com/us/podcast/tmf-daily/id1726037751
Spotify:  https://open.spotify.com/show/0Pl9eqFpghzCwLJSSLgDAQ
iHeartRadio:  https://iheart.com/podcast/143516412
Follow me:
LinkedIn: https://www.linkedin.com/in/nicole-m-palmer-ms-7718b3201/
Instagram: https://www.instagram.com/tmf_enthusiast/
Website: https://tmfdaily.podbean.com/
Enjoy the show!
#etmf #trialmasterfile #clinicalresearchcareers
 
 
 
 
 
 

Tips to Break Into the TMF Industry with No Experience

Breaking into the Trial Master File industry with no experience can be hard. With the right strategy and mindset, it can increase your chances of landing a job offer. Today we are talking about how to stand out from the crowd.
Our sponsor: Granular Level, we're your TMF professionals! We can help you revamp your resume, cover letter, thank you follow-up email, create an eye-catching LinkedIn profile, mock interview and our famous eTMF Specialist course that will give you hands-on eTMF experience.
www.granularlevel.com
You're watching TMF Daily where we talk about anything related to the Trial Master File, from industry standards, regulations, career tips, and interviews with TMF experts.
Welcome to the show, I'm your host, Nicole Palmer.
Make sure to hit the ‘subscribe’ button, and don’t forget to click the bell icon. ➡️ YouTube: https://www.youtube.com/@TMFDaily Enjoy the show!