Clinical Data Coordinator 2

Quanticate; Bengaluru; Hybrid; INR 600,000 - 900,000; Full time

Job summary

Quanticate is seeking a Clinical Data Management professional to support end-to-end activities across multiple studies in Bengaluru. You will assist with database testing, validate study databases, review CRFs for data quality, and manage data queries and DCFs to ensure regulatory compliance.

The role involves collaborating with offshore teams, maintaining study documentation, and contributing to process improvements while upholding high standards of quality and data integrity.

Qualifications

• Experience in Clinical Data Management (CDM)
• Familiarity with ICH-GCP guidelines and data handling regulations
• Hands-on with at least one CDM system (Oracle Clinical, Medidata Rave, Inform)

Responsibilities

• 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

Skills

Attention to detail

Analytical thinking

Written and verbal communication

Organizational skills

Time management

Team collaboration

Offshore/remote collaboration

Microsoft Word & Excel

Tools

Oracle Clinical

Medidata Rave

Inform

Job description

Role & responsibilities

What Youll Do

• 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

What Youll Gain

• Exposure to full lifecycle Clinical Data Management across diverse studies
• Hands-on experience working with industry-leading CDM systems
• Opportunity to collaborate with cross-functional and global teams
• Development of leadership, coordination, and project oversight skills
• A supportive environment that values quality, compliance, and continuous improvement
• Career growth within a regulated and evolving clinical research setting

Preferred candidate profile

Knowledge:

• 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

Work Experience:

• 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

Skills:

• 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