Clinical External Data Specialist

A leading biotech organization based in the San Francisco Bay area is seeking an External Clinical Data Specialist for a remote 8+ month, renewable contract assignment.

The External Data Acquisition Specialist (FSP) will support clinical trials by managing the acquisition, review, conformance, and quality control of external clinical data
. This role focuses on ensuring that externally sourced data are delivered on time, meeting sponsor-defined standards, and conform to expected formats, structures, and specifications.

• Manage end-to-end acquisition of external data sources (e.g., central labs, imaging, ePRO/eCOA, wearables, PK, biometrics, and other vendors)
• Perform external data conformance checks against sponsor-defined specifications, standards, and transfer agreements
• Review external data for completeness, structure, format, and consistency prior to integration or downstream use
• Identify, document, and escalate external data issues, discrepancies, and non-conformance findings
• Coordinate with vendors, data providers, and internal stakeholders to resolve external data conformance issues
• Maintain documentation related to external data transfers, conformance results, and issue resolution
• Support study milestones, interim data deliveries, and database lock activities related to external data

• Bachelor’s degree in Life Sciences, Health Sciences, Data Science, or related field
• Minimum 2 years of experience in Clinical Data Management with a focus on external data
• Hands-on experience managing external vendor data and data transfers
• Strong understanding of external data flow in clinical trials
• Experience performing data quality and conformance checks
• Knowledge of ICH-GCP, data standards, and regulatory expectations

• Prior experience in an FSP or sponsor-dedicated model
• Familiarity with CDISC standards (SDTM concepts related to external data)
• Experience working with multiple external vendors and data types
• Strong issue-tracking and documentation skills
• High attention to detail and data quality focus
• Ability to work independently within sponsor-defined processes
• Strong communication and collaboration skills
• Proactive issue identification and resolution