External Data Specialist

External Data Specialist Overview

• The External Data Specialist ensures accurate processing of external and local lab data throughout clinical trial lifecycles.
• Collaborates with Clinical Data Management teams to maintain data integrity and consistency across assigned projects.
• Supports study start-up and build activities, ensuring compliance with ICH/GCP guidelines and clinical trial methodology.
• Performs quality control checks on laboratory normal ranges and external data test transfers for accuracy and compliance.
• Develops exception listing specifications and visualizations for local lab and external data processes.
• Provides study-specific metrics and reporting to Clinical Data Management and Project Management teams.
• Works closely with cross-functional teams to identify and mitigate risks using clinical data analytics technologies.
• Supports mentoring activities for Lab Admin teams under the guidance of the Manager, External Data.
• Participates in internal and external study team calls to support data processes and reporting requirements.

External Data Specialist Key Responsibilities & Duties

• Communicates data issues and validation problems to Clinical Data Managers and study teams.
• Reviews study protocols and eCRF designs, providing recommendations for data aggregation and capture.
• Ensures clinical databases align with external vendor data requirements and standards.
• Maintains reconciliation logs and change logs for external data processes.
• Develops and performs quality control checks on exception listing specifications and visualizations.
• Supports the setup and implementation of external vendor data transfer agreements.
• Provides metrics and reporting for local lab and external vendor data-driven processes.
• Collaborates with cross-functional teams to ensure effective data trending and risk mitigation.
• Mentors team members and supports development activities within the department.

External Data Specialist Job Requirements

• Bachelor of Science degree in a health-related field or equivalent experience preferred.
• Medical Laboratory Technology certification is advantageous.
• Proficiency in Microsoft Office applications and clinical data management systems.
• Understanding of ICH/GCP guidelines and clinical trial methodologies.
• Strong organizational skills with the ability to multitask and manage multiple projects.
• Excellent communication skills and ability to work collaboratively within teams.
• Knowledge of vendor data processing and clinical data management processes.
• Experience with electronic data capture systems and clinical data analytics technologies.
• Detail-oriented with a commitment to maintaining data confidentiality and integrity.