A day in the life of an eTMF Specialist

We recently interviewed Jeremy Houguenade who we helped progress in his career by finding him a role as an eTMF Specialist at Takeda in Zurich, Switzerland.

Jeremy in terms of qualifications had a Master’s Degree in engineering biotechnology at the NSTBB, Bordeaux, France. He also had completed a Certificate of Advanced Studies in Clinical Research Management Regulatory and Legal Requirements of Clinical Trial Planning at the University of Basel.

He had also worked in the clinical arena for quite a few years gaining experience before progressing to his career goal of working within the clinical field.

Jeremy in this interview explains what it is like to do this role daily and what it involves:

A man being interviewed

1. What is your job title?

eTMF Specialist

2. What is the name of the company you work at?

Takeda

3. What is your background? qualifications and work experience)

I have a Master’s Degree in Biotechnology Engineering. I worked for 7 years as a Scientific Associate in Novartis, then 1 year as Clinical Trial Associate also at Novartis.

4. What does your job involve?

My role is to ensure that all the documentation produced during clinical trials are filed and valid so that the company is inspection-ready
at any time.

5. What is a typical day like in your role?

I usually work on a specific study, on a previously agreed timeline. I review the documents in scope of that quality check cycle – is it filed in the right place, does it fulfil all the legal and ICH-GCP requirements? Do we have all the versions filed?
I also follow-up with the owners of the documents to make sure issues are corrected. In parallel, I am also the point of contact for eTMF-related questions.

6. How did you get into your current job role? (Did you need a certain qualification or experience?)

I had one year of experience in eTMF already, I believe this was critical.

7. What do you enjoy most about your job?

I am involved in a range of clinical studies, in contact with many people. We also get to design the processes ourselves, we are improving them constantly.

8. What is the hardest part of your job?

The hardest part of the job is that this role is perceived as ‘the bad role’ in the sense that our job is to point out mistakes and issues.

9. Why did you decide to pursue this career?

I found working on clinical documentation as an entry point to enter the clinical field. It gives the basic knowledge to later pursue a career in this area.

10. What can this type of job lead to?

It can lead to any position in the clinical field, but the most obvious jobs would be in clinical documentation or clinical operations.

11. What advice would you give to somebody considering this role as a career?

One needs to be detail-oriented for this position, to be able to spot what an inspector could see.

Thank you to Jeremy for taking part in our interview, hopefully, this will have inspired others to look at similar roles as a career path.

If you would like to browse our other articles in our ‘a day in the life of series’ take a look here.