Clinical Data Coordinator II Job in Bengaluru at Quanticate India Pvt. Ltd.

Quanticate is hiring for the role of Clinical Data Coordinator II!

Responsibilities of the Candidate:

• Support end-to-end Clinical Data Management activities across multiple studies
• Assist with database testing and validation prior to study activation
• Prepare and maintain study-specific Data Management documentation
• Review CRFs critically, identifying data inconsistencies, errors, or missing information
• Raise, track, and resolve data queries and Data Clarification Forms (DCFs)
• Manage self-evident queries and allowable data changes within the database
• Perform quality control checks on data entry and database outputs
• Support study close-out activities, including preparation of archival documentation
• Ensure compliance with SOPs, ICH-GCP, regulatory requirements, and client standards
• Contribute to process improvement initiatives and data management best practices
• Perform medical coding activities when assigned
• Collaborate with offshore data processing and programming teams
• Provide project updates and support progress tracking using reports and metrics
• Take on ad-hoc tasks as required to support project and team objectives

Requirements:

• Strong understanding of Clinical Data Management processes
• Solid knowledge of ICH-GCP guidelines and regulatory requirements related to data handling
• Familiarity with CRO and sponsor-driven study standards
• Prior experience in Clinical Data Management or a similar role
• Hands-on experience with at least one CDM system (e.g., Oracle Clinical, Medidata Rave, Inform)
• Experience supporting multiple studies or managing competing priorities is preferred
• Excellent attention to detail and strong analytical thinking
• Good written and verbal communication skills
• Strong organizational and time-management abilities
• Ability to work effectively in a fast-changing, deadline-driven environment
• Comfortable working with offshore or remote teams
• Proficient in Microsoft Word and Excel
• Team-oriented mindset with the ability to motivate and collaborate effectively