Summary
Overview
Work History
Education
Skills
Certification
PERSONAL DETAILS
Accomplishments
Timeline
Generic

Arun Kumar Kannan

Chennai

Summary

Technical Project Support with 12+ years of experience in the Clinical and Insurance domains, particularly in Interactive Response Technology (IRT). Served as the primary technical contact for assigned projects, acting as the liaison between ICON and clients to ensure smooth project execution and client satisfaction. Led and managed the full software development lifecycle (SDLC), from requirements gathering and design through development, validation, deployment, and ongoing maintenance. Reviewed, approved, and maintained comprehensive project system documentation to ensure accuracy and compliance with internal standards. Collaborated with cross-functional teams, including Clinical Operations, to ensure successful project delivery and alignment with client needs. Maintained confidentiality of project information and upheld data security protocols throughout all phases of the project. Ensured that all project deliverables met or exceeded client expectations for quality, functionality, and timeliness. Expertise in Quality Management Reviews, Configuration Verification, and Data Handling using Oracle SQL and Microsoft SQL Server. Proven track record in validation processes, defect tracking, and database testing within highly regulated environments. Adept at mentoring, compliance auditing, and working closely with cross-functional teams to ensure quality delivery.

Overview

13
13
years of professional experience
1
1
Certification

Work History

Senior Compliance Specialist

ICON Clinical Research India Pvt Ltd
04.2015 - Current
  • Clients: Amgen, Pfizer, Celgene, BMS, and other global pharma clients
  • Projects & Responsibilities:
  • Led the project system change control process, ensuring systematic handling of changes while minimizing risks and maintaining project integrity.
  • Contributed to process improvements, optimizing project workflows, adding value to ICON, and enhancing client satisfaction.
  • Acted as the point of contact for external stakeholders, addressing project-related concerns and ensuring smooth communication.
  • Configuration Verification: Reviewed post-deployment configurations, logged discrepancies via Polarion and Helix, and validated against URS and SRS.
  • Quality Management Review: Conducted database reviews against URS, prepared quality templates, and collaborated with project managers for resolution.
  • Production Data Handling: Extracted, validated, tested, and loaded client data into IRT systems. Maintained documentation for audit trails.
  • Additional Contributions:
  • Mentored and trained new team members.
  • Assisted with internal/external audits and CAPA initiatives.
  • Managed quality communications with cross-functional teams.

Data Support Analyst

ICON Clinical Research India Pvt Ltd
03.2013 - 04.2015
  • Supported backend data validation.
  • Assisted QA and compliance teams in data testing and configuration support.

Customer Support Executive

Tata Business Support Services
05.2012 - 12.2012
  • Delivered front-line customer support in a high-volume call center.

Education

B.E. - Computer Science & Engineering

Saveetha University
01.2011

HSC - undefined

MAK Matriculation Hr. Sec. School
01.2007

SSLC - undefined

MAK Matriculation Hr. Sec. School
01.2005

Skills

  • Interactive Response Technology (IRT) Systems
  • End-to-End Database Testing & Validation
  • Quality Compliance & Documentation (GxP, 21 CFR Part 11)
  • Defect Management & Root Cause Analysis
  • Configuration Verification & Requirement Traceability
  • SQL Query Optimization & Data Extraction
  • Audit Preparation & CAPA Implementation
  • Cross-functional Collaboration & Mentoring
  • Risk Assessment & Impact Analysis
  • Agile & Waterfall Methodologies

Certification

  • UiPath RPA Developer Advanced Certificate – Issued: 2020-04

PERSONAL DETAILS

Languages Known: English, Tamil

Accomplishments

  • Zero audit findings across multiple regulatory inspections.
  • Recognized for consistent quality delivery and team mentoring.

Timeline

Senior Compliance Specialist

ICON Clinical Research India Pvt Ltd
04.2015 - Current

Data Support Analyst

ICON Clinical Research India Pvt Ltd
03.2013 - 04.2015

Customer Support Executive

Tata Business Support Services
05.2012 - 12.2012

HSC - undefined

MAK Matriculation Hr. Sec. School

SSLC - undefined

MAK Matriculation Hr. Sec. School

B.E. - Computer Science & Engineering

Saveetha University
Arun Kumar Kannan