Clinical Data Specialist: External Lab & Vendor Data

Socket.dev; United States; On-site; USD 85,000 - 110,000; Full time

Job summary

eClinical Solutions is seeking an External Data Specialist to process external and local lab data across the clinical trial lifecycle. You will help ensure data integrity, review data documentation, and QC deliverables in collaboration with the Clinical Data Management team.

Your daily duties include data validation, protocol reviews for data capture design, and maintaining logs and reports while coordinating with internal and external stakeholders to uphold data standards and timelines.

Qualifications

• BS in health-related field or equivalent
• Medical Laboratory Technology certificate preferred
• Excellent command of English (written and verbal)
• Ability to maintain confidentiality of data and information
• Understanding of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology
• Basic understanding of medical terminology
• Strong teamwork and collaboration
• Ability to work independently and manage multiple projects
• Detail oriented with strong organizational skills
• Knowledge of clinical data management processes and vendor data processing

Responsibilities

• Communicate data issues to study team and external vendors.
• Perform QC of laboratory normal ranges prior to entry to ensure ICH/CGP compliance and accuracy.
• Enter and QC Lab Normal Range data to meet processing deliverables on time.
• Review study protocols and local lab data design for data aggregation and capture.
• Ensure the clinical database aligns with external vendor data and supports data requirements.
• QC external data test transfers for acceptance and accuracy.
• Maintain external data reconciliation and change logs.
• Verify normal ranges are linked to patient results in local lab data collection modules.
• Review external vendor data and local lab listings; raise queries as needed.
• Support startup and build activities for local lab and external vendor data.
• Develop data exception listings and visualizations, QC outputs for production.
• Support setup and implementation of external vendor data transfer agreements
• Provide study-specific local lab and/or external vendor data-driven metrics to management
• Participate in cross-functional study team calls to support data processes
• Collaborate with data analytics technologies for reporting and risk mitigation
• Mentor Lab Admin team on External Data tasks
• Perform other duties as assigned

Skills

Attention to detail

Communication skills

Team collaboration

Independent multitasking

Data management knowledge

Education

Bachelor of Science in health-related field

Medical Laboratory Technology certificate

Job description

eClinical Solutions is seeking an External Data Specialist to process external and local lab data across the clinical trial lifecycle. You will help ensure data integrity, review data documentation, and QC deliverables in collaboration with the Clinical Data Management team.

Your daily duties include data validation, protocol reviews for data capture design, and maintaining logs and reports while coordinating with internal and external stakeholders to uphold data standards and timelines.