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Trial Master File Specialist

Q: Is this program the right fit for me?

To become a CRA, you will typically need a bachelor’s degree in a life science or healthcare-related field, such as biology, chemistry, nursing, or pharmacy. However, some employers may accept degrees in other fields if you have relevant work experience.In addition to a degree, it is beneficial to have experience working in the healthcare or research industry. This can include positions such as a research assistant, laboratory technician, or nurse. Other skills for a CRA include attention to detail, strong organizational and communication skills, the ability to work independently and as part of a team, and problem-solving abilities. Proficiency in Microsoft Office and other relevant software is also important.If you are not sure if this is the right training for you, we are happy to help you make the right decision. Email us at academy@viares.com and we will contact you.

Start your clinical research career and unterstand the role and responsibilities of a Trial Master File Specialist during Clinical Trials. Take on roles responsible for managing the Trial Master File, which is the collection of all essential documents related to a clinical trial.

What you will learn

Gain a comprehensive understanding of the structure, purpose, and regulatory requirements of the TMF, ensuring accuracy and compliance in clinical trials.

Learn the importance of thorough documentation within clinical trials and the key responsibilities of a TMF Specialist in maintaining complete and accurate records throughout all study phases.

Understand the guidelines and standards, including ICH-GCP, that govern TMF management and how to effectively apply these in real-world scenarios to support trial integrity and regulatory compliance.

Acquire the skills to prepare and maintain the TMF for regulatory inspections and audits, ensuring that your documentation supports the reliability and credibility of trial data.

Why VIARES?

✓ Globally accredited & industry recognized

✓ Join 9,000+ members worldwide

✓ Making you the best candidate for the job

✓ All the tools you need to level up your career

Read our 273 verified reviews

Program structure

Role & Responsibilities of a TMF Manager During Clinical TrialsBEGINNER
1 lesson • 1 assignment • 1 knowledge check • 12 hours

MASTER THE ESSENTIALS OF TMF MANAGEMENT IN CLINICAL TRIALS

This module equips you with the fundamental knowledge and practical skills needed to excel as a TMF Manager in clinical trials. You will delve into the critical aspects of documentation management, understand the structure and content of a TMF, and learn the primary responsibilities of a TMF Manager across various study phases. By the end of this module, you’ll be adept at ensuring accuracy and completeness in clinical trial documentation, which is crucial for regulatory compliance and successful trial outcomes.

Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.

✓ Understand the purpose of a Trial Master File (TMF) and its significance in clinical trials.

✓ Learn about the different TMF formats and how to manage them effectively.

✓ Explore the main tasks and responsibilities of a TMF Manager during different study phases.

✓ Gain insights into the importance of accuracy and completeness in maintaining a TMF.

Your instructor:

GABI DISSELHOFF

Regulatory & Quality expert
38 years in pharmaceutical development

Trial Master File StructureBEGINNER
1 lesson • 1 assignment • 1 knowledge check • 12 hours

MASTER THE ESSENTIALS OF TMF STRUCTURE

This module will equip you with a comprehensive understanding of the Trial Master File (TMF) structure, an essential component in clinical research. You’ll delve into the detailed aspects of the TMF, ensuring you can maintain accuracy and completeness in all your documentation efforts.

Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.

✓ Explain the detailed structure of a TMF
✓ Describe the different TMF zones and their functions
✓ Outline the Reference Model as the “gold standard”
✓ Understand the importance of accuracy and completeness in a TMF

Your instructor:

GABI DISSELHOFF

Regulatory & Quality expert
38 years in pharmaceutical development

Trial Master File - Set Up, Maintenance and ArchivingBEGINNER
1 lesson • 1 assignment • 1 knowledge check • 12 hours

MASTER THE ESSENTIALS OF TRIAL MASTER FILE MANAGEMENT

Dive deep into the critical aspects of maintaining a Trial Master File (TMF) with this comprehensive module. You’ll gain a thorough understanding of the regulatory requirements and best practices for setting up, maintaining, and archiving TMFs, ensuring your clinical trials are managed efficiently and comply with all necessary guidelines.

Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.

✓ Understand the purpose and key pillars of a TMF.

✓ Gain familiarity with regulatory requirements and guidelines related to TMFs.

✓ Learn the role of the TMF in trial management and inspection.

✓ Understand the requirements for archiving and retaining TMF documents after the trial.

✓ Know how to set up and organize a TMF.

✓ Ensure the completeness and accuracy of documents in the TMF.

✓ Maintain ongoing TMF maintenance throughout the trial.

✓ Prepare and present a final TMF report to stakeholders.

Your instructor:

GABI DISSELHOFF

Regulatory & Quality expert
38 years in pharmaceutical development

Investigator Site File (ISF) incl. Pharmacy Site File (PSF)BEGINNER
1 lesson • 1 assignment • 1 knowledge check • 12 hours

MASTER THE ESSENTIALS OF CLINICAL DOCUMENTATION

In this module, you’ll gain a comprehensive understanding of the importance of meticulous documentation within a clinical trial. By exploring the structure and content of both the Investigator Site File (ISF) and the Pharmacy Site File (PSF), you will learn how to ensure accuracy and completeness in clinical research documentation.

Download the syllabus for a detailed overview of all lessons, assignments, reading materials, and a general overview.

✓ Understand the critical importance of documentation in clinical trials.

✓ Explore the detailed structure of an ISF and a PSF.

✓ Learn the best practices for maintaining accuracy and completeness.

✓ Gain insights from experts in the field.

Your instructor:

GABI DISSELHOFF

Regulatory & Quality expert
38 years in pharmaceutical development

Certification Exam
Exam • 2 hours

This exam will help you apply your newly acquired knowledge and skills, covering a wide range of topics from the certificate program to ensure your readiness for a position in clinical research.

Explore the full curriculum in pdf and receive email reminders when enrollment closes:

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Duration: 50 hours

Study 2 hours a week to finish in 3 months

4 modules + official certificate

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What VIARES members get

Your membership to VIARES includes everything you need to excel in your clinical research career.

Worldwide LinkedIn community

Connect with peers worldwide to share insights, best practices, and engage in thought-provoking discussions.

Comprehensive Resource Library

Access a vast collection of templates, tools, and playbooks to enhance your clinical research work.

Career center

Redefine your career trajectory and fast-track your personal growth with powerful career mapping and feedback tools.

Easy Learning Portal

Enjoy a user-friendly platform that makes accessing course materials and resources straightforward and convenient.

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Develop the latest and most in-demand clinical research skills with 100% online and globally recognized courses.

VIARES is known by the world’s leading organizations for for clinical reasearch providing you with the best training for your future dream job!

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Why should I enrol in this Trial Master File Specialist course?

Becoming a Trial Master File (TMF) Specialist can be a rewarding career path for individuals who have a strong attention to detail and organizational skills, as well as an interest in clinical research. Here are some reasons why you may want to consider becoming a TMF Specialist:

Growing demand: As the pharmaceutical and biotech industries continue to expand, there is an increasing need for professionals who can manage and maintain the documentation required for clinical trials. The demand for TMF Specialists is expected to grow in the coming years, providing job security and growth opportunities.
Important role: TMF Specialists play a critical role in ensuring that clinical trials are conducted in accordance with regulatory requirements and industry best practices. They are responsible for creating and maintaining the TMF, which contains all essential documents related to the trial, including study protocols, informed consent forms, and regulatory approvals.
Variety of work: TMF Specialists work with a wide range of stakeholders, including clinical trial sponsors, study sites, and regulatory agencies. They must also have knowledge of relevant regulations and guidelines, such as ICH-GCP, FDA regulations, and GDPR. This variety of work can make the role interesting and engaging.
Attractive compensation: The salary of a Trial Master File (TMF) Specialist can vary depending on factors such as location, level of experience, industry, and employer. According to data from Glassdoor, the average base salary for a TMF Specialist in the United States is around $70,000 per year. However, salaries can range from around $45,000 to over $100,000 per year. Other factors that can affect salary include educational qualifications, professional certifications, and additional skills such as knowledge of specific software or languages. It’s important to note that these figures are just estimates and may vary depending on a variety of factors.
Career advancement: With experience and expertise, TMF Specialists can advance to higher-level positions within their organizations, such as a TMF Manager or a Clinical Operations Manager. These roles typically come with higher salaries and increased responsibilities.
Personal fulfillment: For individuals who are passionate about improving patient outcomes and advancing medical research, working as a TMF Specialist can be personally fulfilling. They can take pride in knowing that their work is contributing to the development of new treatments and therapies that can improve people’s lives.

In summary, becoming a TMF Specialist can offer a challenging and rewarding career path for individuals who are interested in clinical research and have strong organizational skills. The role offers job security, growth opportunities, and the ability to make a meaningful contribution to medical research.

What are the typical responsibilities of a Trial Master File Specialist?

The responsibilities of a Trial Master File (TMF) Specialist can vary depending on the organization they work for and the specific clinical trials they are involved in. However, here are some typical responsibilities that a TMF Specialist may have:

Develop and maintain the TMF: The TMF Specialist is responsible for creating, organizing, and maintaining the TMF, which contains all essential documents related to the clinical trial. This includes study protocols, informed consent forms, regulatory approvals, and other important documents.
Ensure compliance: The TMF Specialist must ensure that all documentation in the TMF is accurate, complete, and complies with regulatory requirements and industry best practices. They may also perform quality control checks to ensure that the TMF meets internal and external audit standards.
Facilitate document exchange: The TMF Specialist may coordinate the exchange of documents between study sites, sponsors, and regulatory agencies. This may involve ensuring that documents are properly formatted, tracked, and stored.
Train team members: The TMF Specialist may train other team members on TMF processes and procedures, ensuring that everyone involved in the clinical trial understands their responsibilities related to the TMF.
Stay up-to-date on regulations: The TMF Specialist must stay up-to-date on relevant regulations and guidelines, such as ICH-GCP, FDA regulations, and GDPR. This may involve attending training sessions and reviewing updates to regulations as they occur.
Provide support to study teams: The TMF Specialist may provide support to study teams by answering questions related to the TMF and providing guidance on documentation requirements.
Implement TMF systems: The TMF Specialist may be responsible for implementing and maintaining electronic TMF systems, such as eTMF or other document management systems.

Overall, the TMF Specialist plays a critical role in ensuring that clinical trials are conducted in accordance with regulatory requirements and industry best practices, by managing and maintaining the essential documents related to the trial.

What is the VIARES certificate?

Upon enrollment you will receive your first certification “Confirmation of Enrollment”. After successful completion of the course and your exam, you get your personal “Course Certificate” including:

course title
contact hours
continuing education units (CEU)
your overall course score
date of completion
personal certificate verification code

We also show you how to best share your certificate on LinkedIn and other social media platforms.

There are several reasons why you might consider getting a CRA certification:

Demonstrated knowledge and commitment: Obtaining a CRA certification demonstrates to employers and colleagues that you have a strong understanding of clinical research processes, regulations, and best practices. It shows your commitment to your career in clinical research and can set you apart from other candidates when applying for jobs.

Increased job opportunities: Many employers prefer or require candidates with CRA certifications for their open positions. Having a certification can make you a more competitive candidate and increase your job opportunities.

Career advancement: A CRA certification can help you advance in your career by opening up opportunities for promotion, leadership roles, and increased pay.

Continuing education: Many employers require ongoing education and professional development, which can help you stay up-to-date with the latest developments in the field.

Overall, obtaining a CRA certification can help you stand out in a competitive job market, demonstrate your knowledge and commitment to your career, and open up opportunities for career advancement and professional development.

Is there a fixed schedule?

No, you can proceed with the course in your own pace. But please keep in mind, that you might have to purchase a course extension in order to continue learning (check the pricing table above).

Is this program the right fit for me?

To become a CRA, you will typically need a bachelor’s degree in a life science or healthcare-related field, such as biology, chemistry, nursing, or pharmacy. However, some employers may accept degrees in other fields if you have relevant work experience.

In addition to a degree, it is beneficial to have experience working in the healthcare or research industry. This can include positions such as a research assistant, laboratory technician, or nurse. Other skills for a CRA include attention to detail, strong organizational and communication skills, the ability to work independently and as part of a team, and problem-solving abilities. Proficiency in Microsoft Office and other relevant software is also important.

If you are not sure if this is the right training for you, we are happy to help you make the right decision. Email us at academy@viares.com and we will contact you.

What alumni say about this program

N/A

Medicine development process and the Regulatory requirements compliance and Quality Assurance Audits and Inspection.

Clinical Research Associate

The 'All in One' order process was easy, accessing materials is straightforward, and content is informative. On-demand access is very convenient for completion.

Clinical trial assistant

I would like to pass it but this days I’m so busy and I don’t have enough time to progress with it

Exceptional

The course is very detailed for its length and gives exactly what one may need to navigate the clinical research landscape and medical science.

VIARES Micro Certificate DATA ANALYSIS

Very informative

Detailed information

Clinical Research Associate Academy

Great learning platform

VIARES is an amazing learning platform. After completing the Clinical Research Associate program, I feel well equipped to take on the role and responsibilities of a CRA with great confidence. I would definitely recommend it!

VIARES Micro Certificate PHASES OF CLINICAL TRIALS

Clinical Research Associate

Great

I have been doing the CRA course for about a month now and so far I am really enjoying it. The lectures are really easy to follow, interesting and informative. I'm looking forward to learning more.

Clinical Trials Assistant Academy

Very Good

I really enjoyed the course. The content was well condensed to what is really important.

VIARES ACADEMY ALL-In-One

Excellent

Clinical Research Associate

The course is amazing journey into clinical research career attainment with deep insights of course units that are enriching ,from which knowledge and skills are drawn from , the course contents so far are rich and contributive to career progress.

very informative

very user friendly and lots of information to gather. Thank you

Clinical Study Coordinator Academy

Course content

Very rich course content.

Excellent

I want to say a big thank you to all VIARES Coordinators, for a well packaged program. It is so easy to understand a well-organized. I have just completed the Clinical Research Associate, it was awesome. I will recommend it to friends.

VIARES ACADEMY ALL-In-One

Fabulous and super powered

The CTA was very informative and had a wide topics covered. I am a fresher to the field but now with the knowledge imparted by all the professionals, I feel empowered, Thank you all. Looking forward to complete the other courses in the All in One Academy, Thank you Viares Team

VIARES ASSESSMENT REVIEW

So far my journey here to become a CRA has been so insightful and impactful. I look forward to more exciting topics and lectures as far as the CRA program is concerned.

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Trial Master File Specialist

What you will learn

Why VIARES?

Program structure

MASTER THE ESSENTIALS OF TMF MANAGEMENT IN CLINICAL TRIALS

Your instructor:

MASTER THE ESSENTIALS OF TMF STRUCTURE

Your instructor:

MASTER THE ESSENTIALS OF TRIAL MASTER FILE MANAGEMENT

Your instructor:

MASTER THE ESSENTIALS OF CLINICAL DOCUMENTATION

Your instructor:

Get free access to our learning portal and experience it yourself

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All in One

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What VIARES members get

Worldwide LinkedIn community

Comprehensive Resource Library

Career center

Easy Learning Portal

Accredited Courses

Job Support

Grow your career

FAQ

What alumni say about this program

Related Clinical Research Programs

Clinical Research Associate

Clinical Research Project Manager Academy

Clinical Study Coordinator I

Study Start Up Specialist

Clinical Operations Specialist

Clinical Research Project Specialist

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