External Data Specialist

External Data Specialist Overview

• The External Data Specialist is responsible for managing external and local lab data throughout clinical trials.
• Ensure data integrity by adhering to departmental SOPs, guidelines, and global standards.
• Collaborate with cross-functional teams to address data-related issues and ensure accurate documentation.
• Support Clinical Data Management with quality control and review of trial deliverables.
• Contribute to the development of data exception listings and associated visualizations.
• Participate in study reporting and data trending to mitigate risks proactively.
• Provide metrics and support for local lab and external vendor data processes.
• Work remotely in a dynamic and collaborative environment.

External Data Specialist Key Responsibilities & Duties

• Communicate data issues to relevant stakeholders and resolve validation problems.
• Perform quality control of laboratory normal ranges and ensure compliance with ICH/GCP standards.
• Review study protocols and provide insights for data aggregation and capture.
• Ensure alignment between clinical databases and external vendor data requirements.
• Maintain external data reconciliation logs and verify data accuracy.
• Develop exception listing specifications and perform quality checks for production readiness.
• Support external vendor data transfer agreements and study-specific data processes.
• Mentor team members and contribute to process improvements.

External Data Specialist Job Requirements

• Bachelor of Science degree in a health-related field or equivalent experience.
• Proficiency in Microsoft Office and clinical data management systems.
• Understanding of ICH/GCP guidelines, 21 CFR Part 11, and clinical trial methodologies.
• Strong organizational skills with the ability to manage multiple projects independently.
• Excellent communication skills and ability to collaborate effectively with teams.
• Knowledge of clinical data management processes and vendor data handling.
• Medical Laboratory Technology certification preferred.
• Detail-oriented with demonstrated computer literacy and accurate keyboarding skills.