Clinical Data Coordinator II
Company: ICON plc
Location: Chennai, India (Office with Flex) (Job Requisition mentions Clinical Data Manager – Bangalore; however, the position is listed as Clinical Data Coordinator II – Chennai.)
Employment Type: Full-Time
Experience Required: 2+ Years
Salary Package
Expected CTC: ₹6 LPA – ₹10 LPA (Estimated market range based on experience, clinical data management expertise, and organization. Actual salary may vary.)
Job Summary
ICON is seeking a Clinical Data Coordinator II to support clinical data management activities across global clinical trials. The role involves maintaining electronic Case Report Forms (eCRFs), managing clinical and third-party data reconciliation, resolving data discrepancies, and ensuring high-quality clinical data in compliance with industry standards and regulatory requirements.
Key Responsibilities
Support the Data Management Study Lead in maintaining electronic Case Report Forms (eCRFs), Data Validation Specifications, and Study-Specific Procedures.
Perform clinical and third-party data reconciliation based on data review plans and edit specifications.
Track study progress and communicate study metrics to Clinical Data Scientists, project teams, and functional management.
Review, identify, and resolve clinical data discrepancies and data-related queries.
Perform root cause analysis to identify recurring data issues and implement effective resolutions.
Ensure data quality, consistency, and completeness throughout the clinical trial lifecycle.
Collaborate with Clinical Operations, Biostatistics, Medical Monitoring, and other cross-functional teams.
Support database quality review and data cleaning activities.
Maintain documentation in accordance with company SOPs, ICH-GCP guidelines, and regulatory requirements.
Contribute to continuous process improvement initiatives within Clinical Data Management.
Required Qualifications
Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Nursing, Healthcare, or a related field.
2+ years of experience in Clinical Data Management within the pharmaceutical, biotechnology, or CRO industry.
Working knowledge of clinical data management processes and clinical trial data standards.
Experience using clinical data management systems such as Medidata Rave, Oracle RDC, or similar Electronic Data Capture (EDC) platforms.
Required Skills
Clinical Data Management (CDM).
Electronic Case Report Form (eCRF) maintenance.
Data validation and data cleaning.
Clinical and third-party data reconciliation.
Query management and discrepancy resolution.
Root cause analysis and problem-solving.
Knowledge of clinical trial processes and data review workflows.
Strong analytical and organizational skills.
Excellent written and verbal communication.
Ability to collaborate effectively with cross-functional global teams.
High attention to detail and commitment to data quality.
Preferred Skills
Knowledge of ICH-GCP guidelines and global clinical research regulations.
Experience with Electronic Data Capture (EDC) systems and clinical databases.
Familiarity with CDISC standards, MedDRA, or WHODrug is an advantage.
Experience working on global or multi-center clinical trials.
Understanding of clinical database lock, data review plans, and validation specifications.
Proficiency in Microsoft Excel and other clinical reporting tools.
Employee Benefits
Competitive base salary with performance-based incentives.
Comprehensive medical, dental, and vision insurance (where applicable).
Retirement and pension plans.
Life insurance and disability coverage.
Employee Assistance Program (EAP).
Health and wellbeing initiatives.
Structured learning and career development programs.
Flexible office-based work model.
Opportunities to work on global clinical trials within a leading Clinical Research Organization (CRO).
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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