External Data Specialist

A leading biotech organization based in the San Francisco Bay area is seeking an External Data Specialist for a remote long term, 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. Key Responsibilities • 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 Required Qualifications • 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 Preferred Qualifications • 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 Key Competencies • 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