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.