Arjun Sridharan

Functional Experience:

· Handled a team end to end Clinical Data Standards specialists/Global Librarians and provided functional leadership in planning, development, and implementation of Industry (CDISC and regulatory) compliant Clinical Data Standards from EDC to SDTM/ADaM TLFs.

Implementation of new TA/disease area fit for purpose standard from concept sheets including the design of instruments to collect, standardize, transform along submission/reporting of clinical trial data.

Cross functional collaboration across clinical trial functions (clinical team, data management, trial management, biostatistics groups) to ensure data collected has proper utilization and meets the needs of expected clinical trial outcomes.

Define global clinical data review check points to ensure the accuracy of clinical data collected from sites and foresee clinical trials are conducted as per protocol to address the key endpoints.

Key stakeholder for data management teams to address risk and provide mitigation plans, support teams from study startups until interim/final locks.

Provided strategic leadership in creating various MDR (Metadata Repository) applications to manage and govern end to end Clinical Data Standards. These applications were automated from CDASH to SDTM dataset creation and enhanced consistency across projects.

· Spearheaded hiring of new Clinical Data Standards associates, trained/mentored, and provided SME support in their required therapeutic areas.

· Gave tactical direction in usage of new tool/technology for development and maintenance of Clinical Data Standards.

· Led and implemented 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.

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

· First line of governance for study teams for potential new collection standards and analysing 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.

People and Project Management:

· Managed and oversee quality of a team of 18 data standards/global library associates to deliver end to end Clinical Data Standards.

· Fostered a culture of continuous improvement by encouraging staff to share innovative ideas.

· Enhanced employee performance through targeted training programs and regular feedback sessions, resulting in higher productivity levels.

· Provide feedback/evaluate associates for year-end performance/appraisals.

· Assisted CROs in managing all aspects of operations.

· Foresee people and projects risks, assess, control and review control measures to manage them.

Functional lead responsible for leading the planning, development, and implementation of
Industry (CDISC and regulatory) compliant clinical data standards
· Lead clinical data standards projects such as end to end strategy for maintenance of Novartis
control terminologies, evaluating new/maintenance of metadata management systems and
defining processes, guidance's and evaluating industry recommendations.
· First line of governance for study teams for potential new collection standards and analyzing
the requirement from data collection till SDTM/ADaM/TLF.
· Hiring new clinical data standards associates, trainings/mentoring and SME support in their
required therapeutic areas.
· Drive innovation and continuous improvement across clinical data standards

Content development using CDISC elements,control terminologies (CDASH/SDTM)
· Presenting the content in data standards/therapeutic area governance with rationale from
collection to analysis perspective
· Implementation of E2E metadata (EDC to SDTM, ADaM) within the metadata system
· 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 for safety and therapeutic area standards
· Knowledgeable in metadata driven approach that defines the transformation required to
submit the data as per SDTM compliant format
· Specialist in processing lab data collection, implementation of lab parameters, units, unit
conversion and implementation of LOINC codes.
· Planning and Implementing of Industry (CDISC and regulatory) compliant Clinical Data
Standards, providing expert support to business users and teams