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Clinical Data Standards SME at TCS, supporting CDISC SDTM regulatory submissions and contributing to a Metadata Repository product.

India

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At Tata Consultancy Services Ltd. (TCS), I serve as an Assistant Manager / SDTM Mapping SME, supporting CDISC SDTM implementation, specification review, dataset validation, and regulatory submission readiness. I also review ADaM datasets and specifications.

I coordinate SDTM mapping and validation for legacy and InForm study migrations, and supported high-priority COVID-19 clinical studies. I guided implementation of the FDA Flat Model concept for vaccine studies.

Within the TCS ADD team, I contribute Life Sciences expertise to a Metadata Repository product and Agentic AI-enabled capabilities. I also volunteer on the CDISC USDM project, working with Merck on protocol-related reviews, and participate in PHUSE volunteering.

Experience

Work history, roles, and key accomplishments

Current

Assistant Manager / SDTM Mapping SME

Current

Tata Consultancy Services

May 2017 - Present (9 years 6 months)

Serve as Subject Matter Expert for CDISC SDTM mapping, implementation, specification review, dataset validation, and technical issue resolution. Lead and coordinate SDTM mapping and validation activities for regulatory submission, and support Define-XML and CSDRG preparation.

CDISC SDTM SDTM Mapping SDTM Dataset Validation Pinnacle 21 Define.Xml CSDRG Adams SAS SQL Pl SQL Oracle Toad Unix data transformation CDARS SQL Navigator Excel R Metadata Repositories Agentic AI

Application Support Specialist

Pay Front Technologies

Jun 2015 - Feb 2017 (1 year 8 months)

Gathered and analyzed business requirements for payroll processing and coordinated delivery of customer requirements. Managed a team of five members, developed reports using SQL scripts, and migrated data to Oracle systems.

SQL Oracle Toad Data Migration Report Development Team Management Business requirements analysis

Clinical Database Programmer

HCL Technologies

Jun 2014 - Sep 2015 (1 year 3 months)

Supported clinical trial study setup using Clinical Trial Systems (CTS) and designed clinical data collection forms, CRF screens, and data validation rules. Performed UAT data entry, validated study setups, and supported SDTM output validation using P21E.

Clinical Trial Systems CRF Design Data Validation UAT SDTM Pinnacle 21