External Data Specialist (Contract)
Core
Processing external and local lab data throughout the clinical trial lifecycle to ensure data integrity and consistency.
Role type
Senior IC clinical data specialist (external/local lab data)
Builds
Clinical trial deliverables including data documentation, quality control reports, and exception listings
Domain
Life sciences / Clinical trials
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
Clinical data management processes, ICH/GCP guidelines, 21 CFR Part 11, medical terminology, data reconciliation, query management, study start-up activities, data visualization, vendor data processing
Preferred skills
Medical Laboratory Technology certificate, basic science degree in health-related field
Technologies
elluminate, eCRF, DMP, IDROP, CCG
Responsibilities
Perform QC of laboratory normal ranges and external data test transfers; Review study protocols and eCRF design for data aggregation; Maintain external data reconciliation logs; Verify normal ranges linked to patient results; Issue queries for data issues; Provide study-specific data metrics; Support set-up of external vendor data transfer agreements; Develop exception listing specifications and visualizations.
Seniority
Mid-level, hands-on IC