Delfi Diagnostics

Data Scientist

• Lead Clinical Data Operations: Own the end-to-end data lifecycle for our clinical studies. Establish timelines and drive team adherence towards interim analysis data cuts, database locks and final validation readouts
• Sample & Data Reconciliation: Manage the complex reconciliation between clinical data (EDC) and biological sample data (LIMS). Ensure the life-cycle of the sample matches the clinical data
• Data Quality & Regulatory Readiness: Own, execute, and oversee compliance with the Clinical Data Management Plan (CDMP). Author and oversee the generation of Data Quality Review listings (DQR) to support IVD clinical validation. Ensure all clinical data activities are inspection-ready. Proactively organize and perform ongoing data review throughout study conduct to ensure timely and appropriate identification of errors, trends, discrepancies, completeness, and quality issues
• Ensure proper closeout and archiving of data management study related materials, e.g., CDMPs, database change documentation, validation documents, and final participant casebooks
• Vendor Oversight: Manage CROs and EDC vendors to ensure they meet DELFI’s standards, study-specific plans, and contractual obligations. Review eCRF designs, edit checks, and UAT specifications to minimize downstream data issues
• Cross-Functional Leadership: Serve as a primary data management representative in clinical study team meetings. Develop and maintain departmental procedures in accordance with regulatory requirements Proactively assess project and CDM issues and risks working with the Clinical Operations team
• Mentorship: While this role is an individual contributor, a critical function will be to provide oversight to deliverables of junior team members

Senior Staff Clinical Data Manager