Clinical Data Specialist

Job Summary

To ensure the accuracy and integrity of clinical trial data, the full-time Clinical Data Specialist will manage data collection, review, and cleaning remotely, while adhering to regulatory compliance and collaborating with various stakeholders throughout the study lifecycle.

Key Responsibilities

• Perform accurate EDC data entry and ongoing data review across multiple studies, ensuring consistency with source documentation
• Maintain study data in EDC, eSource, CTMS, and related systems, while supporting study startup activities and identifying workflow improvements
• Ensure data handling complies with GCP/ICH, FDA regulations, and maintain accurate documentation of data management activities

Required Qualifications

• 2-5 years of clinical research data management experience, including EDC entry
• Strong working knowledge of GCP, ICH, FDA regulations, HIPAA, and the clinical trial lifecycle
• Hands-on experience with major EDC/eSource platforms and Microsoft Office
• High attention to detail and strong organizational skills
• Ability to manage multiple studies simultaneously