Data Acquisition Specialist
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• Define and deliver standardized External Data Streams and related documents.
• Assess protocol-driven external data collection needs and plan setup activities to meet study timelines.
• Collaborate with data stakeholders to define data transfer, ingestion, and structure per data protection laws and standards.
• Create change requests for new data concepts or structures related to external data.
• Develop trial-specific data transfer agreements (tsDTA) detailing study requirements and ingestion methods.
• Ensure data transfer frequencies meet study requirements for review, monitoring, and analysis.
• Coordinate with external data providers to align tsDTA and data transfer terms.
• Translate medical/scientific concepts into data mapping guidance within the annotated DTA for Clinical programmers.
• Perform User Acceptance Testing to verify data transfers align with DTA specifications.
• Implement data transfer mechanisms into the Clinical Data Repository (CDR) and enable external provider access.
• Monitor availability and accuracy of external data streams and resolve conformance issues with providers. Responsabilidades
• Bachelor's degree or equivalent, preferably in Computer Science
• Minimum 3 years' experience managing data in clinical research
• Experience with external data (Safety Lab, PK, biomarkers, ECG, etc.)
• Experience engaging with external data providers in a clinical study setting
• Experience developing data transfer agreements
• Experience working on clinical trials
• Experience in diverse, cross-functional, multiregional teams
• Knowledge of SDTM
• Working knowledge of GCP/ICH guidelines
• Excellent written and verbal English communication Requisitos principales
• remote work
• home-based
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