Sr External Data Specialist
Core
Manage processing, quality control, and validation of external and local laboratory data throughout the clinical trial lifecycle for life sciences clients.
Role type
Senior External Data Specialist (Clinical Data Management)
Builds
High-quality clinical datasets for digital trials and analytics platforms
Domain
Life Sciences / Clinical Trials / Clinical Data Management
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Clinical trial methodology, ICH/GCP guidelines, 21 CFR Part 11, external data source handling, quality control (QC), data validation, study start-up, data transfer agreements, clinical database management, process improvement, cross-functional collaboration
Preferred skills
Medical Laboratory Technology certificate, AI/ML and advanced analytics utilization, digital transformation experience
Technologies
elluminate Clinical Data Cloud, Electronic Data Capture (EDC) systems, Microsoft Office Applications
Responsibilities
Perform QC of laboratory normal ranges and external data test transfers; Act as primary study contact and SME for external data processing; Review study protocols and eCRF designs for data aggregation; Verify normal range linkage to patient results; Drive implementation of data transfer agreements; Provide data-driven metrics and KPIs to project management; Identify and mitigate data risks using analytics; Facilitate cross-functional team training.
Seniority
Senior, hands-on IC with mentoring responsibilities
