Clinical Data Coordinator II
Company: ICON plc
Location: Chennai, India (Office with Flex)
Employment Type: Full-Time
Experience Required: 2–4 Years (Estimated based on the role level and responsibilities.)
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 (CDC II) to support clinical data management activities for global clinical trials. The role involves maintaining clinical databases, ensuring data quality, managing data reconciliation, and collaborating with cross-functional teams to deliver accurate, complete, and regulatory-compliant clinical trial data.
Key Responsibilities
Assist 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 edit specifications and data review plans.
Monitor and communicate study progress, task metrics, and data management status to Clinical Data Scientists, project teams, and functional management.
Review and resolve clinical data queries while recommending appropriate solutions.
Conduct root cause analysis to identify and resolve recurring data quality issues.
Ensure accuracy, consistency, and completeness of clinical trial data throughout the study lifecycle.
Support database cleaning and quality review activities.
Collaborate with Clinical Operations, Biostatistics, Medical Monitoring, Statistical Programming, and other cross-functional teams.
Maintain study documentation in accordance with company SOPs, ICH-GCP guidelines, and regulatory requirements.
Participate in continuous process improvement initiatives to enhance data management quality and efficiency.
Required Qualifications
Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Nursing, Healthcare, or a related field.
2–4 years of experience in Clinical Data Management within the pharmaceutical, biotechnology, or CRO industry.
Intermediate knowledge of clinical data management processes and clinical trial data standards.
Experience working with Electronic Data Capture (EDC) systems such as Medidata Rave, Oracle RDC, or similar 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.
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.
Ability to work efficiently in a fast-paced environment.
Preferred Skills
Knowledge of ICH-GCP guidelines and global clinical research regulations.
Familiarity with Electronic Data Capture (EDC) systems and clinical databases.
Understanding of CDISC standards, MedDRA, or WHODrug coding concepts is an advantage.
Experience working on global or multi-center clinical trials.
Knowledge of database lock processes, data review plans, and validation specifications.
Proficiency in Microsoft Excel and other clinical data management tools.
Employee Benefits
Competitive base salary with performance-based incentives.
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 :
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