Should I Be A Data Manager or TMF Specialist?

TMF specialist is the new uprising position in CRO industry because TMF files are required for the study trials. CROs and sponsors always want clean TMF because these TMF files contain all the necessary documents relevant to the study that are to be submitted to the sponsor at the end of the study. All the important documents are collected from the site and from CRA and put into TMF but here are so many missing files in TMF as delegation logs and monitoring letters. For this purpose they hire TMF specialist.

1.     TMF specialist:

TMF specialist is the person who is kept in charge of TMF who directly reports to the project management team on the status of TMF. His only duty is to manage and arrange all the documents within TMF that are the most important deliverables to sponsors.

TMF specialists make enough amount of money and have all the understanding of ins and outs of the TMF but there is a downside of working as a TMF specialist because they become bound for managing and setting TMF and analyzing the health of the TMF.

2.     Data manager:

Data management professional is the person who works on management side and manages the data for the study. They are at the most benefit because they can make easy transitions in clinical operation side as monitoring and they work hand in hand with CRAs and in-house monitors in monitoring the data.

They have capabilities and skills for analyzing data and data management and they can use their skills as leverage to work in any other company in case of CRO downfall.



Data manager is preferable over TMF specialist because of the above mentioned qualities that are making everything clear. Data managers are very flexible as compared to TMF specialist as they can do many other tasks, work with many other employees and can get experience of various other fields. They can move further up the ladder to project director and vice-president of the department

Working for both positions of TMF specialist and project management for a couple of years is most beneficent because it gives you the understanding and skills of both sides’ clinical studies. Where you can have the experience in various aspects as managing TMF, clinical updates, data management updates, study startup updates. These all the experiences can provide high chances of career progressions in CRO industry.


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