DELFI Diagnostics · 14 hours ago
Senior Staff Clinical Data Manager
Palo Alto, CA
Full-time
Hybrid
Senior Level, Lead/Staff
$150K/yr - $210K/yr
10+ years expDELFI Diagnostics is developing next-generation, blood-based tests to help detect cancer. The Senior Staff Clinical Data Manager will lead clinical data operations, ensuring the integrity and timely delivery of clinical data while mentoring junior team members.
Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical
Responsibilities
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
Leverage Modern Tools: Work directly within Databricks to review data. Instead of waiting for static PDF listings, you will query data (SQL) or run existing QC scripts (R/Python) to identify discrepancies in real-time
Bridge the Gap: Act as the translator between Clinical Development and Data Engineering. When the data engineers build pipelines, you define the clinical logic. When the clinical team needs data, you help them access it self-service
Digital Health Adaptation: As we integrate new digital health endpoints, you will adapt our data management processes to handle EMR and real world data alongside traditional EDC data
Qualification
Required
10+ years of Clinical Data Management experience (or 8+ with an advanced degree), ideally at a Sponsor company within an IVD or Medical Device environment
Expert-level knowledge of Electronic Data Capture systems
Expert knowledge of GCP, ICH, CDISC/SDTM
Deep understanding of what inspection-ready data looks like and how to deliver it
Comfortable writing SQL to query a database
Exposure to R or Python for data review
Track record of hitting aggressive database lock timelines without compromising quality via strong cross-functional collaboration
Experience partnering with and leading CRO data management teams
Understanding of how to partner with vendors to ensure high quality, on-time deliverables
Preferred
Direct experience with diagnostic studies and the unique challenges of linking biological sample data to clinical data
Familiarity with the oncology therapeutic area via clinical trials and/or biomarker studies
Experience in lean, rapidly evolving environments and comfort owning a broad scope
Familiarity with interactive coding environments (e.g., Jupyter, RMarkdown, Databricks) for reproducible data review and analysis
Company
DELFI Diagnostics
Delfi Diagnostics detects cancer early, when it is most curable, using high precision non-invasive blood tests.
51-200 employees
H1B Sponsorship
DELFI Diagnostics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2023 (4)
2022 (1)
2021 (2)
Funding
Current Stage
Growth StageTotal Funding
$364.83MKey Investors
DFJ GrowthOrbiMedMenlo Ventures
2025-12-18Debt Financing· $34.33M
2022-07-18Series B· $225M
2021-01-12Series A· $100M
Leadership Team
Susan Tousi
CEO
Amoolya Singh
Chief Technology Officer
Recent News
BioWorld Financial Watch
2026-01-11
Bizjournals.com Feed (2025-11-12 15:43:17)
2026-01-07
Company data provided by crunchbase