Soumya Rajesh

How long have you been volunteering at CDISC?

Since the end of Oct 2013.

What encouraged you to volunteer your time and expertise with CDISC?

As I gained expertise in the area of SDTM standards and over time lead projects in SDTM conversion, as well as mentored co-workers and team members in the best practices and use of SDTM standards, I felt I could contribute to the industry better by volunteering my time at CDISC. Fred Wood inspired me to be a CDISC SME. 😊

How did you begin working in clinical research?

I actually drifted into the job – Octagon Research Solutions hired me as a Regulatory Operations Associate for electronic publishing / eSubs work in Jul 2005. They gave me the opportunity to work with SDTM data conversion when the HR manager observed that I had the right skill set. That was in Oct 2005, and here I still am.

What did you want to be when you grew up?

I certainly did not imagine that I would be a CDISC Standards Engineer / SME. 😊 I have come a long way with my dreams evolving along the road over the years.

You are on track to become a CDISC-authorized instructor. What led you to pursue this on top of your other volunteering responsibilities at CDISC?

I think some of that is already covered in my response to question #2; however I’d like to add that my experience over the years in this industry, especially in the area of SDTM and collaborating with different cross-functional teams led me to believe I could extend my knowledge and help spread the right use of standards, especially since they have become a mandate from Dec 2016.

Please provide a tip that someone would find helpful in working with CDISC Standards.

I think - the thirst for knowledge, a sense of Clinical Data flow, patience with hearing differing views, and asserting one’s opinion at the right place and time – is the key to succeeding in CDISC standards.