Summary
Overview
Work History
Education
Skills
Personal Information
Awards
Timeline
CustomerServiceRepresentative
THARSILA AROKIASAMY

THARSILA AROKIASAMY

Clinical data Lead
Trichy

Summary

Dynamic Clinical Data Coordinator with over 12 years of invaluable expertise in data management and validation. Proven ability to streamline processes and enhance data quality across clinical research projects. Adept at mentoring teams and fostering collaboration to achieve optimal results in data handling and project execution. Strong background in managing complex data sets and ensuring adherence to quality standards, contributing to successful study outcomes. Committed to leveraging analytical skills and strategic thinking to drive advancements in clinical data coordination.

Overview

16
16
years of professional experience
2005
2005
years of post-secondary education
2
2
Languages

Work History

Clinical Data Lead

ICON Clinical Research India (P) Ltd.
02.2023 - Current

Responsible for Clinical data Validation, Query generation and Integration.

Identify and appropriately address data discrepancies in the clinical data via computerized edits and manual checks/listings(Lab, SAE, ePro, eCOA, Pk &PD Reconciliation)

Primary contact for client DM/study teams/clinical team for all data management related study enquiries.

Primary contact for quality deliverables across setup/conduct and closeout phase by frequent meetings with Client and Third-Party Vendors.

Generate, review for accuracy and distribute status reports as requested. CPT review. UAT, Specification writing, test scripts creation.

Perform quality review for new resources, Organize teleconference and team meetings, and Project documentation for Audits.

Participated in Study Kick Off meetings and all study related meetings till study Close-out to track data management activities and ensure project milestones are met according to agreed timelines with high quality.

Provided guidance to the study teams offshore and provided comments after database review, testing and defining edit checks specifications for assigned studies.

§Handled Phase I to Phase IV clinical trials data management activities that include study setup, conduct and closeout phases.

Acted as primary contact for all data management solutions, issues and questions from study teams and responsible for issue resolutions and have coordinated with offshore Data Managers/Team Leads/Data Management Project Lead.

Business Analyst

ICON Clinical Research Organization
01.2022 - 01.2023

Business Analyst :

Review and approve URS documents, UAT check list

Maintaining all the report documents, filing them in appropriate location.

Meeting with clients and programmer

Assign Reports to programmer

Publish the Reports in Prod Environment.

Senior Clinical Data Coordinator

ICON Clinical Research Organization
01.2016 - 12.2022

·Discrepancy Management

·Review and validation of programmed listings.

·3rd Party external vendor data reconciliation and management

·CRF Tracking, DCF creation, updates, and Query Management

·Manual and Auto Identification and resolution of data discrepancies

·Reconciliations (SAE, PK, BioMarker, IVRS, LAB, ePRO etc.)

·Individually handled CPPC’s for many studies.

Part of all major milestones (including paper CRF study, EDC study and transition of ongoing conduct study) and achieved them on or before time.

Quality Review.

·Interim and Final database transfer

·QC data listings/Data.

·Freezing and locking activities

Agency Manager

Kotak Mahindra Life Insurance
03.2015 - 09.2016
  • Promoting Business for kotak life insurance co Ltd, Recruiting and Handling Agency Managers, Team Leaders, Agents
  • Conduct weekly meetings and Training for development of team members
  • Address customer and employee satisfaction issue promptly
  • Maintaining Good relationship with Agency Managers, Team Leaders, Agents and motivating to promoting the business and creating convention and contest qualifiers in the same
  • Following up the logged in cases for Conversion on time

Clinical Data Coordinator II

ICON Clinical Research Organization
01.2009 - 05.2013

Ø Includes CRF Review, Discrepancy Management in different platforms such as Oracle Clinical and Inform

Ø Responsible for Clinical data Validation, Query generation and Integration.

Ø Identify and appropriately address data discrepancies in the clinical data via computerized edits and manual checks/listings.

Ø Generate data queries to resolve data discrepancies.

Ø DCF Update including coding prior to database lock

Ø Identify and accurately resolve all workflow or clinical data discrepant issues.

Ø SAE reconciliation with the Oracle database and the clinical database

Ø Timely input for CRF designing and Data management plan

Ø Assist with the validation of edit check programs. Assist with the development, review and the update of relevant Data Management Study Specific Procedures.

Ø Generate listings and perform data accuracy review

Ø Study overview presentation and Protocol Presentation

Ø Generate, review for accuracy and distribute status reports as requested.

Ø Perform quality review for new resources, Organize teleconference and team meetings, and Project documentation for Audits.

Effectively mentor less experienced staff. This may include assisting and guiding new personnel during their initial training period

Data Analyst/Team Coordinator

Cognizant Technology Solution
09.2008 - 01.2009

KEY RESPONSIBILITIES

Identification of data discrepancies via computerized edit checks and manual data checks.

Review, update and correct data in the clinical database based on resolved data queries.

Perform additional data reviews activities to provide high quality data. Update tracking systems as necessary. Creation and maintenance of study files and other study documents.

Playing key role in process evaluation and redesign of data validation and UAT. Manage projects working with global teams. Trained and mentored junior data management staff on UAT, Client Specific application/tool, QC and Data validation.

MAJOR ROLES

Preparing Visit matrix

Giving inputs to SSU team and CRF designers§User Acceptance testing

Preparing Data Check Specification

Preparing Data Standard Documents

Preparing Data Management Plan and Data Entry Instructions

Data Validation

DQF Updating

QC

Maintaining Trackers

Education

Bachelor of Science - Bio-Chemistry

Holy Cross College

Master of Science - Bio-Technology

Holy Cross College

Master of Philosophy - Bio-Technology

Ponnaiya Ramajayam College

Skills

  • Ms Office
  • Adobe Photoshop
  • Excellent Team Player
  • Professional Ethics
  • Leadership Qualities
  • Quick Learner

Personal Information

  • Gender: Female
  • Nationality: Indian
  • Marital Status: Single

Awards

  • ICON Inspired Award – 2021(ICON):For excellence in Study coordination and extraordinary time commitment.
  • COVID Award – 2020 (ICON): For Best Support and contribution during COVID 19 pandemic.
  • ICON Inspired Award – 2020 (ICON): For Accountability and Delivery and team player.
  • Inspired Award – 2019(ICON): For Accountability and Delivery.
  • ICON Cheer Award – 2018(ICON):Team Coordination, and handled multiple study. Successfully locked Study with good quality.
  • ICOAWARD – 2011 (ICON): For excellence in Study coordination and extraordinary time commitment.
  • Outstanding performance award from Astrazeneca Client – 2008 (Cognizant Technology solution):AZ-DMC was honored outstanding performance award for excellence in Study management, Effective Leadership, and successful completion of project on time. Also Certified as Certified Level 1 trainer for Client Specific Tool SPOLA in 2008 (Cognizant Technology solution)
  • ICOAWARD – 2007 (ICON)For excellence in Study coordination, successfully passed all time lines and delivered good quality work with no major observations.

Timeline

Clinical Data Lead

ICON Clinical Research India (P) Ltd.
02.2023 - Current

Business Analyst

ICON Clinical Research Organization
01.2022 - 01.2023

Senior Clinical Data Coordinator

ICON Clinical Research Organization
01.2016 - 12.2022

Agency Manager

Kotak Mahindra Life Insurance
03.2015 - 09.2016

Clinical Data Coordinator II

ICON Clinical Research Organization
01.2009 - 05.2013

Data Analyst/Team Coordinator

Cognizant Technology Solution
09.2008 - 01.2009

Bachelor of Science - Bio-Chemistry

Holy Cross College

Master of Science - Bio-Technology

Holy Cross College

Master of Philosophy - Bio-Technology

Ponnaiya Ramajayam College
THARSILA AROKIASAMYClinical data Lead