Soumya Rajesh

Soumya Rajesh

Sr. Standards Engineer, Global Data Standards


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. ๐Ÿ˜Š

How did you begin working in clinical research?

I actually drifted into the job โ€“ 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. ๐Ÿ˜Š 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 Iโ€™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 oneโ€™s opinion at the right place and time โ€“ is the key to succeeding in CDISC standards.