Clinical Data Coordinator

Responsibilities

• Collect, enter, and manage clinical trial data using electronic data capture (EDC) systems.
• Perform data validation and query management to ensure data quality and compliance with study protocols.
• Assist in the development of case report forms (CRFs) and data management plans (DMPs).
• Conduct ongoing data review and discrepancy resolution in collaboration with clinical staff.
• Generate data listings and summaries for interim and final study reports.
• Ensure data handling is in compliance with GCP, ICH guidelines, and applicable regulatory requirements.
• Maintain study documentation, audit trails, and data queries logs.
• Participate in cross-functional study team meetings and contribute to project timelines.

• Bachelor's degree in life sciences, healthcare, information technology, or related field.
• 13 years of experience in clinical data management or a related clinical research role.
• Familiarity with EDC systems (e.g., Medidata Rave, Oracle Clinical, REDCap).
• Knowledge of GCP, ICH, and regulatory guidelines.
• Excellent attention to detail, organizational, and communication skills.
• Proficiency in Microsoft Excel and other data management tools.