RAJKUMAR SOMASUNDARABHARATHI

• Provided oversight for multiple studies within organization, managing studies and Data Management staff.
• Developed productive working relationships with cross-functional stakeholders, providing strategic support to project teams.
• Attended program-level strategic meetings and set program-level data collection and review standards.
• Contributes to the Request for Proposal (RFP) and Request for Information (RFI) process. Prepares input and participates in proposal bid defence meetings.

Project Management and Leadership:

• Efficiently planned, coordinated, and delivered high-quality clinical trial data for assigned projects.
• Provided leadership in aligning and driving data collection requirements for complex clinical development projects.
• Led end-to-end clinical data management activities, overseeing third-party vendors and enforcing data standard conventions.
• Authored and reviewed/revise DM-related study plans, ensuring quality and standardization.
• Supported SOP and Work Instructions creation and involve in continuous improvement of process
• Represented DM on cross-functional project teams, portfolio review meetings, and Submission Teams. • supported inspections and audits.

Line Management:

• Managed over 10 Data Management staff based on business requirements.
• Assigned resources to initiatives, ensuring appropriate support for clinical trials' data quality oversight.
• Forecasted team member needs and proposed solutions to meet potential constraints.
• Coached and mentored staff, supporting individual development plans and fostering culture of diversity and accountability.
• Line management responsibilities for all assigned direct reports, including professional development/training, Performance appraisals, Employee counseling, Performance management issues, interviewing, and selection; assignment of project work; and workload reviews.

• Responsible and accountable for managing all Data Management activities with respect to quality and timelines for all assigned projects/trials within Clinical Program.
• Working as key collaborator and strategic partner with stakeholders ensuring that data management activities for clinical trials.
• Ensures consistency on design of trials within program/indication

• Worked as operational lead for 2 global studies
• Managed delivery of projects through full data management study life-cycle.
• Contributed to successful regulatory inspections by maintaining well-organized documentation of all clinical trial activities related to data management.

• Wrote and instituted Data review Plan, Study Plan Specification, CRF Completion Guideline, Performed screen UAT, Views UAT, Edit check UAT, SAS UAT, Eportal data Validation, DHP.

• Point of contact to monitor data flow, discrepancy management and all other data management activities.
• Conducted thorough quality control checks on completed datasets, ensuring the highest level of data integrity.

• Worked in Oncology studies as a primary DM for the study.
• Performed UAT and supported conduct and Closeout activities