Trial Master File Specialist

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.

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This course is planned to start on July 07, 2023

We train and certify you

Successfully complete the four competency modules below to obtain your VIARES Trial Master File Specialist Certificate.
  • 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
  • Detailed insights into the TMF structure and its content
  • Essential documents 
  • Detailed insights into the TMF set up and its index
  • Document Management Plan
  • TMF Archiving
  • 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 

The VIARES Certification is an online exam covering 80+ questions from the VIARES training course. You need to complete the exam within 75 minutes and achieve at least 80% of all points to be graded positive. You have two attempts, of which the attempt with the higher score is applied for your certification.

After successful completion of the exam, you will be graduating the VIARES program and obtain your certificate.

Requirements

This program will be of benefit to anyone with first relevant work experience, ideally in clinical research as a Clinical Research Associate. Also, (aspiring) Data Managers that wish to expand their knowledge of remote and central monitoring activities will benefit from this training.

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.

WHY BECOME A Trial Master File Specialist?

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 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.

IS THIS THE BEST OPTION FOR ME?

To become a Trial Master File (TMF) Specialist, it is helpful to have a background in life sciences or a related field, as well as experience in research or administration. Here are some typical qualifications and skills that can be beneficial for individuals interested in becoming a TMF Specialist:

  • Education: A bachelor’s degree in a life sciences field, such as biology, chemistry, or healthcare administration, is usually preferred. Some employers may also require a master’s degree or higher.
  • Experience: Experience working in research or administration is highly valued.
  • Knowledge of regulatory requirements: A strong understanding of relevant regulations and guidelines, such as ICH-GCP, FDA regulations, and GDPR, is important. This may involve completing training courses or obtaining certifications in these areas.
  • Attention to detail: A TMF Specialist must be highly detail-oriented and have excellent organizational skills. They must be able to manage a large volume of documents and ensure that everything is accurately recorded and maintained.
  • Communication skills: Good communication skills are important for a TMF Specialist, as they will be required to communicate with study teams, regulatory agencies, and other stakeholders.
  • Technology skills: Experience with electronic document management systems and proficiency with Microsoft Office applications, such as Excel and Word, can be helpful.
  • Certifications: Obtaining certifications may also be beneficial.
 
Overall, a combination of education, experience, and relevant skills can be valuable for individuals interested in becoming a TMF Specialist. It’s also important to stay up-to-date on the latest developments and trends in clinical research and regulatory requirements.

WHY GET A CERTIFICATION?

Obtaining a Trial Master File (TMF) Specialist certification can be beneficial for several reasons:

  • Demonstrates expertise: Obtaining a TMF Specialist certification demonstrates that you have the knowledge and skills required to manage and maintain a TMF in accordance with regulatory requirements and industry best practices. This can be valuable for employers who are looking for individuals with specific expertise in this area.
  • Enhances job opportunities: Having a TMF Specialist certification can make you more competitive in the job market, as it demonstrates your commitment to the field and your willingness to invest in your own professional development.
  • Increases earning potential: Individuals who hold a TMF Specialist certification may be eligible for higher salaries, as they are recognized as having specialized knowledge and expertise.
  • Supports career advancement: Having a TMF Specialist certification can support career advancement by demonstrating your expertise and commitment to the field, and can help you qualify for more senior roles in clinical research or clinical trial administration.

Overall, obtaining a TMF Specialist certification can be a valuable investment in your career, providing you with recognition for your expertise, enhancing job opportunities and earning potential, and supporting career advancement.

This is a snapshot of the latest new entries from our full list of global clinical research jobs. Our list is updated and curated for you daily, adding hundreds of new jobs. Get full access with a VIARES account.

NEW JOBS POSTED TODAY

This is a snapshot of the latest new entries from our full list of global clinical research jobs. Our list is updated and curated for you daily, adding hundreds of new jobs. Get full access with a VIARES account.

Position – click to go to jobCompanyLocationDate CreatedSourceTitleId (key)
Position – click to go to jobCompanyLocationDate CreatedSourceTitleId (key)

Description

Get ready for the future of monitoring

Alternative ways of monitoring trial data have been in place for several years, actively being promoted by lawmakers but hesitantly utilized in clinical trials. The global COVID-19 pandemic has brought remote and centralized monitoring techniques to the forefront and created an environment in which requirements for monitors are quickly shifting away from being focus on on-site visits towards the use of centrally aggregated data to support the data review.

The avenue to new monitoring techniques is now more than ever paved for Data Managers and Clinical Research Associates alike, and having a firm understanding of regulations and guidelines as well as first insights into the daily business of remote monitoring will give you the edge as CROs and Sponsors alike are looking to expand their teams.

A Flexible Online Setup

Our setup enables you to complete this program either next to a full-time job or in a focused effort. 100% of the program is online and most of the training courses can be completed at any time.

You can start the training right away and complete it at your own pace. This training contains 40 hours of online material.

You do not need to wait for a kick-off date, you can start your training anytime – as early as today if you wish.

Get Certified & Job Ready

On successful completion of this program, you will be certified and will have acquired knowledge, skills and competencies to start at an entry level role as Clinical Research Associate, In-House Clinical Research Associate or similar.

The VIARES Clinical Research Associate program is more than just a training. It’s a life-changer!

Certificates:

  • VIARES, GCP

Life-time payment plan includes:

  • all benefits from the monthly payment plan with only one payment
  • PLUS – unlimited life-time access to your training course
  • PLUS – free download of your training course handouts for offline learning
 

Monthly payment plan includes:

  • registration fee
  • all online-training course material
  • online access to our learning management system
  • mini-exams during the training to test your knowledge
  • VIARES exam – 2 attempts included
  • personalized certificate upon completion
  • join career events at no cost
  • free access to our weekly updated global job list
  • apply to exclusive job offers
  • get your personal career coaching
  • any time free cancellation of monthly payment
 

Your expert instructors

Joanna Wilinska Mackowiak

Andreas
Beust

Hear from our graduates

Teresa

Teresa

The VIARES Talent Program is an opportunity for achieving more in-depth knowledge regarding the Clinical Trials, but it is also suitable for those who are looking for a career change and thus, new to the Clinical Trials Field. Extensive live training

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with professionals was provided throughout the program, knowledge checks, and assignments which were later discussed during the sessions.
I strongly recommend the VIARES Talent Program and its team.

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Ioana

Ioana

The VIARES Clinical Research Academy Program offers a great way to learn the basics of clinical research and monitoring. I am now confident in my knowledge and ready to take the next steps on this path. The VIARES team is always there to guide

[expand]

you and the experienced tutors are keeping you focused while presenting the informative courses. Thank you VIARES for the opportunity to take part in this exciting program!

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reviews curated by judge.me

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Trial Master File Specialist
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