What is a Trial Master File (TMF) Specialist?

TMF is in bad shape all across the industry and the position of TMF specialist is cropping up. TMF specialist is the person who has to make sure the completeness of the TMF and ensuring that it’s up-to-date because these are required by the sponsors at the end of the study.


Sponsors have been frustrated because of bad shape of TMF and it’s the issue of all the CROs as they don’t have any appoint person for this task. TMF is not maintained throughout the course of the study and when it’s time to deliver them to sponsors, the whole team has to spend a lot of time and money to reconcile all the documents into the TMF.


Here comes the need of the TMF specialist position which is determined as the position that will be very beneficial for helping the company to save a lot of money, stress and time at the end of the study. They keep the TMF up-to-date during the study.

Benefits entry-level personnel:-

This is a good position for the entry level personnel as they get access to a lot of essential documents, monitoring reports, actual protocols, financial disclosure forms, medical licenses and CVS. They get understanding of all the necessary requirements regarding to the TMF and information related to clinical research from all those documents.

Not an entry level role:-

It can be difficult for someone who is new to clinical research industry and have no experience to get into the clinical research industry for TMF specialist position if it’s not an entry level position. Industry demand experience individuals having better understanding and knowledge of data, TMF and document management. This is a very specialized role as they only have to manage TMF.


TMF is the most important deliverable to be delivered to the sponsor at the end of the study but it face difficulties as it’s not the priority of the monitors. Remote monitors have so many other responsibilities to perform instead of collecting documents. They do not find it necessary for themselves to scan all those documents and sending them to TMF. At the end of the study when TMF is required but they find a lot of documents as missing. This cost them much money and time for collecting all those documents from sites and monitors which can be very difficult.

Duties of TMF specialist:-

Duties of TMF specialists include monitoring the health of TMF files during the course of the study trials. They audit TMF, assess internal quality, and ensure that they are placed, dated, signed and named properly. They have to make sure that all the documents are in the TMF. They can discuss his needs with the study team in the internal meeting which occur weekly during the study. They express their wish for the desired document from the site, relaying the over-all health of the TMF to the study team.


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