Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Rajkumar Somasundarabharathi

Chennai

Summary

Experienced Clinical Data Manager with 15+ years in the CRO industry and pharma. Specializing in project and line management of global clinical studies. Proven expertise in Clinical Data Management (CDM), including oversight of vendors, adherence to CDISC standards, and Good Clinical Data Management Practices (GCDMP). Skilled in project management, risk mitigation, regulatory inspection readiness, and driving data quality. Adept at collaborating across global teams, fostering inclusivity, and mentoring high-performing data management professionals. Excel in communication, teamwork, and problem-solving to ensure projects meet deadlines and exceed expectations.

Overview

15
15
years of professional experience
1
1
Certification

Work History

Principal Project Data Manager

Syneos Health
11.2018 - Current
  • Provided strategic oversight for multiple global studies, managing CDM deliverables and ensuring compliance with DM standards and GCDMP.
  • Served as primary liaison with third-party DM vendors, managing delivery against KPIs, budget, and timelines.
  • Authored and reviewed DM-related plans (e.g. DMPs, CRF completion guidelines) and supported regulatory inspections/audits.
  • Led risk identification/mitigation strategies for DM activities, ensuring integrity of clinical databases.
  • Represented DM on cross-functional project teams, submission teams, and portfolio reviews.
  • Mentored and line-managed over 10 DM staff, supporting professional development, performance management, and resource forecasting.

Principal Clinical Data Manager

Novartis
07.2017 - 10.2018
  • Accountable for end-to-end data management activities across multiple trials, ensuring data quality and adherence to timelines.
  • Collaborated with stakeholders to drive consistency in trial design and data collection strategies within programs.
  • Directed DM vendor performance and supported system validation activities, including EDC and related clinical data systems.

Senior Clinical Data Coordinator

Quintiles
02.2016 - 06.2017
  • Operational lead for global studies, managing delivery through full DM study lifecycle.
  • Supported regulatory inspections with robust documentation and data quality processes.

Data Analyst

Cognizant Technology Services
05.2014 - 01.2016
  • Authored study specifications, CRF completion guidelines, and data review plans; led UAT, SAS validation, and EDC implementation.

Clinical Data Associate

ICON Clinical Research
09.2011 - 05.2014
  • Primary point of contact for data flow, discrepancy management, and data integrity across multiple studies.

Trainee Junior Data Analyst

Cognizant Technology Solutions
02.2010 - 08.2011
  • Supported UAT and closeout activities in oncology studies, ensuring data accuracy.

Education

Masters - Biotechnology

University of Madras
01.2007

Skills

  • Project leadership
  • Line management
  • Team development
  • Inspection/audit readiness
  • Strong communication
  • Stakeholder collaboration
  • Vendor management
  • Performance evaluation
  • Cross-functional communication

Certification

Certified Clinical Data Manager (CCDM), Society for Clinical Data Management, 2023

Timeline

Principal Project Data Manager

Syneos Health
11.2018 - Current

Principal Clinical Data Manager

Novartis
07.2017 - 10.2018

Senior Clinical Data Coordinator

Quintiles
02.2016 - 06.2017

Data Analyst

Cognizant Technology Services
05.2014 - 01.2016

Clinical Data Associate

ICON Clinical Research
09.2011 - 05.2014

Trainee Junior Data Analyst

Cognizant Technology Solutions
02.2010 - 08.2011

Masters - Biotechnology

University of Madras
Rajkumar Somasundarabharathi