Job Title: Clinical Data Coordinator II (CDC II)
Location: India – Chennai, Trivandrum, Bangalore (Office with Flexibility)
Company: ICON plc
Employment Type: Full-Time
About the Role:
ICON plc, a global leader in healthcare intelligence and clinical research, is seeking a Clinical Data Coordinator II (CDC II) to join our team. This role plays a critical part in managing, analyzing, and interpreting clinical trial data, ensuring high-quality data management processes, and supporting the advancement of innovative treatments and therapies.
Key Responsibilities:
Assist the Data Management Study Lead in the maintenance of electronic Case Report Forms (eCRFs), Data Validation Specifications (DVS), and Study Specific Procedures (SSPs).
Manage reconciliation of clinical and third-party data based on edit specifications and data review plans.
Track and communicate study and task metrics to Clinical Data Scientists, project teams, and functional management.
Address data-related questions and provide recommendations for resolutions.
Identify root causes of data issues and implement systematic solutions to maintain data integrity.
Required Experience & Skills:
Bachelor’s degree in Life Sciences, Healthcare, or a related field.
Minimum 5 years of relevant experience in clinical data management within pharmaceutical or biotechnology settings.
Intermediate knowledge of clinical data management processes, eCRF handling, and data validation.
Familiarity with clinical data management systems such as Medidata, Oracle RDC, or similar platforms.
Strong attention to detail and ability to work efficiently in fast-paced environments.
Excellent communication skills and ability to collaborate across cross-functional teams.
Knowledge of regulatory guidelines and standards (e.g., ICH-GCP) is a plus.
Core Competencies:
Clinical data management and reconciliation
Data validation and quality control
eCRF and study documentation management
Problem-solving and root cause analysis
Collaboration and cross-functional communication
Why Join ICON:
Opportunity to contribute to high-impact clinical trials and innovative healthcare solutions.
Competitive salary and comprehensive benefits, including health insurance, retirement planning, life assurance, and wellness programs.
Flexible working options and a supportive office environment.
Inclusive culture that fosters diversity, professional growth, and career advancement.
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