Arjun Sridharan

· Handling a team of clinical data standards/global librarians and providing functional leadership in planning, development, and implementation of Industry (CDISC and regulatory) compliant clinical data standards from EDC to SDTM

· Providing strategic leadership in creating various MDR (Metadata repository) applications to manage and govern end to end clinical data standards. These applications automate CDASH to SDTM dataset creation and enhance consistency across projects.

· Hiring new clinical data standards associates, trainings/mentoring and SME support in their required therapeutic areas.

· Providing tactical direction in development of new tool/technology for development and maintenance of clinical data standards.

· Leading and implementing the below clinical data standards projects:

An application which consolidates various CDISC (CDASH, SDTM, ADaM, DEFINE, PROTOCOL, GLOSSARY) control terminologies published by NCI through an automated process. This application also collects sponsor specific code list and serves as a reference for all clinical trials.

Contribute and propose sponsor specific code list values to CDISC

(TEST/TESTCD/METHOD/SPECIMEN/UNITS/CONVERSION) for all applicable finding domains.

First line of governance for study teams for potential new collection standards and analyzing requirement from data collection till SDTM/ADaM/TLF.

Drive innovation and continuous improvement across clinical data standards.

eCRF/DTS Content development using CDISC elements, control terminologies (CDASH/SDTM)

Design of eCRF/DTS through Medidata Rave (Medidata Certified) platform by using CDASH standards.

Usage of SDTM implementation guide and therapeutic area user guides (TAUG)

Expert in creation of CDASH global libraries using Medidata Rave EDC for safety and therapeutic area standards.

Vast experience using lab administration, architect, global library modules within Rave classic and Rave EDC application.

Specialist in processing lab data collection, implementation of lab parameters, units, unit conversion and implementation of LOINC codes.

Validate SDTM datasets using PINNACLE21 checks.