Clinical Data Coordinator II (Senior) – ICON
Location
Chennai, India
Trivandrum, India
Bangalore, India
Work Mode
Office or Home (Hybrid/Flexible)
Job Type
Full-time
Department
Clinical Data Management / Clinical Data Sciences
Experience Required
Relevant experience in Clinical Data Management (CDM) within:
Pharmaceutical industry
Biotechnology companies
Contract Research Organizations (CROs)
Experience managing clinical trial data, eCRFs, data review, and reconciliation activities preferred.
Estimated Salary Package (Market Standard)
₹8 – ₹15 LPA (approx.), depending on clinical data management experience, EDC system knowledge, and technical skills.
Job Overview
The Clinical Data Coordinator II (Senior) at ICON supports clinical data management activities for global clinical trials. The role involves maintaining clinical databases, managing data review activities, supporting data validation processes, resolving data issues, and collaborating with cross-functional clinical teams to ensure accurate, complete, and compliant clinical trial data.
The position contributes to the delivery of high-quality clinical data supporting the development of innovative medicines and therapies.
Key Responsibilities
Clinical Data Management Activities
Support Clinical Data Management (CDM) study activities.
Assist Data Management Study Leads with:
Electronic Case Report Form (eCRF) maintenance
Data Validation Specifications (DVS)
Study-specific procedures
Ensure clinical data is accurate, complete, and compliant with study requirements.
Data Review & Reconciliation
Perform clinical data review activities according to study plans.
Manage reconciliation of:
Clinical data
External/third-party data sources
Apply edit checks and data review specifications.
Identify inconsistencies and ensure timely resolution of data discrepancies.
Data Issue Management
Address clinical data-related queries and provide appropriate solutions.
Perform root cause analysis for recurring data issues.
Support systematic resolution of data quality challenges.
Escalate critical data issues when required.
Study Metrics & Reporting
Track and communicate study and task-related metrics.
Provide status updates to:
Clinical Data Scientists
Project Teams
Functional Management
Support monitoring of study timelines and deliverables.
Cross-Functional Collaboration
Collaborate with:
Clinical Data Managers
Clinical Scientists
Project Managers
Functional teams
Participate in study meetings and operational discussions.
Support successful delivery of clinical trials.
Educational Qualification
Required:
Bachelor’s degree in a relevant field such as:
Life Sciences
Healthcare Sciences
Pharmacy
Biotechnology
Related disciplines
Required Skills
Intermediate knowledge of Clinical Data Management processes.
Understanding of clinical trial lifecycle.
Experience with clinical data management systems such as:
Medidata
Oracle RDC
Similar EDC platforms
Strong attention to detail and data accuracy focus.
Ability to work effectively in a fast-paced clinical research environment.
Strong written and verbal communication skills.
Ability to collaborate with global cross-functional teams.
Preferred Skills
Knowledge of regulatory guidelines:
ICH-GCP
Clinical trial data standards
Data quality requirements
Experience with:
eCRF design
Data validation
Query management
Third-party data reconciliation
Exposure to global clinical trials.
Work Environment
Flexible office/home-based working model.
Collaboration with global clinical research teams.
Opportunity to work on pharmaceutical and biotechnology clinical trials.
Who Should Apply
Clinical Data Coordinators
Clinical Data Associates
Junior Clinical Data Managers
Data Management Specialists
Professionals with experience in EDC systems, clinical trial data review, query management, and ICH-GCP-compliant data processes looking to grow their career in global Clinical Data Management.
Uttar Pradesh :
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Remote, India | Siliguri |Illinois :
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