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Trial Master File Specialist

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33 views

Trial Master File Specialist

Uploaded by

fwn886w4wh
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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TRIAL MASTER

FILE SPECIALIST

Quick facts
4 Modules
What our Graduates Say

Copyright © 2022 VIARES GmbH All rights reserved. viares.com


Take your next career step.
Explore the basics of Clinical Research.
The VIARES TRIAL MASTER FILE SPECIALIST program is more than just training. We aim
to improve employability as Clinical Research Professionals for our participants.

Our setup enables participants to complete their program next to a full-time job or in a
focused effort. On successful completion of this program graduates will have acquired
knowledge, skills and competencies to understand the basics of the clinical research de-
velopment process.

The all-online TRIAL MASTER FILE SPECIALIST program provides an intensive training in
line with industry competency framework.

You can start the program anytime and complete it at your own pace. Your training content
is ready for you today and you have access for 12 months.

Why become a clinical research professional?


• exciting job opportunities and career perspectives
• contribute to better health care
• diversity of tasks and responsibilities
• opportunity to work in a multi-disciplinary and multi-cultural environment
• apply technical skills combined with professional skills and behaviors

Why is VIARES different from others?


VIARES programs are built to enable you to progress in your career in clinical
research. We train talents like you to become effective and responsible CRAs.
Our full-service approach makes the difference:

• join no matter where you are located as we are global


• define the schedule of activities
• the most affordable, comprehensive online training program
• ACRP membership and certification, a gold-standard in the industry
• career services to improve your chance for the next job

More than a training


We will not only train you. We will support you with
getting your dream job with personalized advice.

As part of the training, you will get:


• Free Access to our Global Job List
• Free Access to Exclusive Jobs with VIARES Partners
• Favorable rates on personalized coaching (conference call 1-1) with a senior expert
recruiter, to support you with your CV, LinkedIn Profile, Interview Preparation and
Salary Negotiation

Copyright © VIARES GmbH All rights reserved. viares.com


4 Moduls

Role and Responsibilities of a


TMF Specialist during Clinical Trials
• Background of TMF management
• The importance of documentation within a clinical trial
• Basic insights into the TMF structure and its content
• Main tasks and responsibilities of a TMF Specialist

Trial Master File Structure


• Detailed insights into the TMF structure and its content
• Essential documents

Trial Master File - Set Up, Maintenance and Archiving


• Detailed insights into the TMF set up and its index
• Document Management Plan
• TMF Archiving

Investigator Site File (ISF)


incl. Pharmacy Site File (PSF)
• The importance of documentation within a clinical trial
• Basic insights into the ISF structure and its content
• Basic insights into the PSF structure and its content
• Regulatory documents

Copyright © VIARES GmbH All rights reserved. viares.com


What our Graduates say about us

VIARES Clinical Research Talent Program is an excellent and timely


opportunity in the era of new drugs and vaccines development. The ho-
listic nature of the program complements my practical understanding of
vaccines and drugs development clinical trials and pharmacovigilance.
I recommend it to people with career aspirations in clinical research.

I passed the final exam on the VIARES Clinical Research Talent Program.
It was fantastic opportunity to gain new knowledge in clinical research
and I would recommend it to anyone interested in the field of clinical trials.
Many thanks to Dietmar Eglhofer for creating this program and all ama-
zing tutors: Eric Klaver, Gavin Chait and Gabriele Disselhoff for very infor-
mative courses and webinars.

The VIARES Clinical Research Talent Program was a fantastic opportuni-


ty to gain and update on new knowledge in the field of Clinical Research
encompassing Clinical Trials, Clinical Data Management and Clinical Data
Regulations. Overall it was a very good experience with quite intensive
learning and an amazing learning and skill development opportunity.

I am really happy that I joined the VIARES CRA Academy, it was an ama-
zing experience filled with valuable information, personal insights from
the professionals, and really interesting topics. I am very satisfied with the
overall structure of the program and would definitely recommend it!

Copyright © VIARES GmbH All rights reserved. viares.com


Start right away
The VIARES program starts once you signed up for it. Kick-off your training today, you
don’t need to wait for a specific date.

We recommend to watch the introduction to kick-off your program. You will get to know
everything to successfully complete your training and get certified.

You can take the program at your own pace yet calculate about 50 hours for your learning
efforts.

Program fee
We offer a simple payment schedule to cover the full program fee. Please visit our website
for details.

The payment schedule of twelve installments is one of our ways to support our talents to
get a top industry quality upskilling at an affordable price. There is no connection to any
program duration.

All information in this document can be subject to change without notice, please refer to
viares.com for updated prices.

About VIARES
VIARES is the leading Online Training providerand Job Support partner for Clinical Re-
search Professionals.

The company was founded in 2018 by 2 industry experts who were formerly working in
leading roles of HR and Scientist in the CRO & Pharma industry.

Our offices are located in the heart of Vienna, Austria, which is a large European Pharma
Hub.

SIGN UP NOW – viares.com


Do you have questions?
Contact us: [email protected]

Copyright © VIARES GmbH All rights reserved. viares.com

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