Clinical Data Coordinator II at ICON - Hybrid Role Across Bengaluru, Chennai & Trivandrum

About ICON

ICON plc is an internationally renowned clinical research and healthcare intelligence organization committed to pioneering innovative medical treatments and enhancing patient care outcomes. Collaborating with leading pharmaceutical, biotech, and medical device companies globally, ICON delivers top-tier clinical development solutions in a diverse and inclusive work environment that promotes continuous improvement and professional development.

Job Overview

The Clinical Data Coordinator II (CDC II) position with ICON's Clinical Data Management team, part of the ICON Strategic Solutions (FSP) division, offers a full-time hybrid work opportunity at Bengaluru, Chennai, and Trivandrum. This role is suited for candidates experienced in clinical trial data management who are eager to contribute to high-quality data integrity on global clinical research projects.

Primary Responsibilities

• Organize and execute risk-based clinical data reviews effectively.
• Collaborate with trial partners to define data review specifications unique to each study.
• Liaise with programming teams to develop and implement data review tools.
• Regularly update and communicate data review status to Clinical Trial Data Managers.
• Ensure timely completion of data review deliverables in alignment with project timelines.
• Participate in initiatives to enhance data management processes and supporting toolkits.
• Implement and promote risk-based management techniques across data review activities.
• Evaluate clinical datasets, reports, listings, visual analytics, and ensure data quality and accuracy.
• Generate, manage, and resolve queries within Electronic Data Capture (EDC) and Clinical Data Management Systems (CDMS).
• Author and review Data Management Manuals and related planning documents.
• Maintain comprehensive clinical trial documentation and facilitate archival procedures.
• Perform data reconciliation and carry out thorough quality assurance checks.
• Contribute to the creation of dashboards and data visualizations for project insights.
• Support audit preparations, respond to inspections, and ensure compliance with regulatory standards.
• Assist in eCRF maintenance, validation specification development, and study operational procedures.
• Monitor study metrics and provide clear communication regarding project progress.
• Investigate clinical data issues and employ root cause analysis for resolution.

Qualifications and Experience

• Bachelor's degree in Healthcare or a relevant field.
• Prior experience in clinical data management in pharmaceutical, biotechnology, or Contract Research Organization (CRO) environments preferred.
• Proficiency with clinical data management platforms such as Medidata, Oracle RDC, or equivalent.
• Strong understanding of ICH-GCP guidelines and clinical trial regulatory requirements.

Skills Required

• Expertise in clinical data management and clinical trial data review
• Knowledge of electronic data capture and eCRF management
• Competency in data validation, reconciliation, and integrity assurance
• Familiarity with Medidata and Oracle RDC systems
• Analytical thinking and problem-solving abilities
• Attention to detail with a focus on data quality
• Effective cross-functional collaboration and communication
• Experience with regulatory compliance and clinical trial documentation
• Ability to perform root cause analysis and risk assessment
• Understanding of data visualization tools and dashboard creation