DELFI Diagnostics · 15 hours ago
Senior Staff Clinical Data Manager
Palo Alto, CA
Full-time
Hybrid
Senior Level, Lead/Staff
$150K/yr - $215K/yr
10+ years expDELFI Diagnostics, Inc. is developing innovative blood-based tests for cancer detection using advanced machine-learning methods. The Senior Staff Clinical Data Manager will lead clinical data operations, ensuring data integrity and compliance for key clinical studies while mentoring junior team members.
Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical
Responsibilities
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
Manage the complex reconciliation between clinical data (EDC) and biological sample data (LIMS)
Ensure the life-cycle of the sample matches the clinical data
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
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
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
Provide oversight to deliverables of junior team members
Work directly within Databricks to review data
Query data (SQL) or run existing QC scripts (R/Python) to identify discrepancies in real-time
Act as the translator between Clinical Development and Data Engineering
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
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