Clinical Data Coordinator II
Company: Quanticate
Department: Clinical Data Management
Employment Type: Full-Time
Experience Required: 2–5 Years (estimated based on role responsibilities and CDM system requirements)
Work Mode: Flexible / As per project requirements
Salary Package
Expected CTC: ₹6 LPA – ₹15 LPA (Estimated market range based on Clinical Data Management experience, CDM system knowledge, CRO exposure, and study complexity. Actual compensation may vary.)
Job Summary
The Clinical Data Coordinator II supports end-to-end Clinical Data Management (CDM) activities across multiple clinical studies. The role is responsible for ensuring data quality, database readiness, query management, documentation compliance, and accurate clinical trial data handling throughout the study lifecycle.
The position involves collaboration with Clinical Data Managers, programmers, offshore data processing teams, sponsors, and cross-functional study teams to deliver high-quality clinical trial data in compliance with ICH-GCP, regulatory requirements, and client standards.
Key Responsibilities
Clinical Data Management Activities
Support complete Clinical Data Management activities across multiple clinical studies.
Assist Clinical Data Managers with study setup, maintenance, and close-out activities.
Prepare and maintain study-specific Data Management documentation.
Support database build, testing, and validation activities before study activation.
Ensure data management deliverables are completed within agreed timelines.
Support clinical trial data review and cleaning activities.
CRF Review & Data Quality Management
Perform critical review of Case Report Forms (CRFs) to identify:
Data inconsistencies
Missing information
Data entry errors
Potential protocol deviations
Raise, track, and resolve:
Data queries
Data Clarification Forms (DCFs)
Self-evident queries
Manage allowable database changes according to study specifications.
Perform quality control checks on:
Data entry
Database outputs
Clinical data listings
Database & System Activities
Support clinical database testing and validation processes.
Work with CDM systems such as:
Oracle Clinical
Medidata Rave
Inform
Similar clinical data platforms
Ensure database functionality aligns with study requirements.
Support database lock preparation and study close-out activities.
Study Documentation & Compliance
Maintain accurate Clinical Data Management documentation.
Support preparation of archival documentation at study completion.
Ensure compliance with:
Standard Operating Procedures (SOPs)
ICH-GCP guidelines
Regulatory requirements
Sponsor-specific standards
Maintain inspection-ready documentation and audit trails.
Cross-Functional Collaboration
Collaborate with:
Clinical Data Managers
Statistical Programming teams
Data Processing teams
Study management teams
Sponsors and external stakeholders
Coordinate with offshore and remote teams to support study deliverables.
Provide project status updates using reports and performance metrics.
Participate in team meetings and operational discussions.
Medical Coding & Additional Support
Perform medical coding activities when assigned.
Support data review activities related to:
Medical terminology
Clinical classifications
Coding dictionaries
Take ownership of additional project-related activities as required.
Process Improvement
Contribute to Clinical Data Management process improvement initiatives.
Support development of best practices and operational efficiencies.
Identify opportunities to improve data quality and workflow processes.
Required Qualifications
Bachelor’s or Master’s degree in:
Life Sciences
Pharmacy
Healthcare
Biotechnology
Related scientific discipline
Required Experience
Prior experience in:
Clinical Data Management
Clinical Data Coordinator role
Similar clinical research data operations role
Experience supporting clinical trials within:
CRO environments
Pharmaceutical companies
Biotechnology organizations
Hands-on experience with at least one Clinical Data Management system:
Medidata Rave
Oracle Clinical
Inform
Similar CDM platforms
Required Skills
Strong understanding of Clinical Data Management processes.
Knowledge of:
ICH-GCP guidelines
Regulatory requirements for clinical data handling
Sponsor and CRO study standards
Strong analytical and problem-solving skills.
Excellent attention to detail and data accuracy.
Good written and verbal communication skills.
Strong organizational and time-management abilities.
Ability to manage multiple priorities in deadline-driven environments.
Comfortable working with global and remote teams.
Proficiency in:
Microsoft Word
Microsoft Excel
Preferred Skills
Experience handling multiple clinical studies simultaneously.
Experience with database validation and testing.
Knowledge of clinical trial lifecycle and study close-out processes.
Experience with query management and reconciliation activities.
Exposure to medical coding activities.
Experience working with global pharmaceutical sponsors.
Familiarity with clinical trial metrics and reporting dashboards.
Benefits
Competitive salary package.
Flexible working hours.
Annual leave, sick leave, casual leave, and holidays.
Medical insurance coverage for employee and immediate family.
Gratuity benefits.
Accidental insurance coverage.
Learning and development opportunities through:
Mentoring
Coaching
E-learning programs
Job shadowing opportunities
Career Opportunity at Quanticate
Opportunity to work with a global data-focused Clinical Research Organization (CRO).
Exposure to complex international clinical trials.
Collaboration with pharmaceutical companies and biotechnology organizations.
Career growth opportunities in Clinical Data Management, Data Operations, and Clinical Research.
Opportunity to contribute to development of therapies through high-quality clinical data.
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