Senior Staff Clinical Data Manager

DELFI Diagnostics, Inc. • Palo Alto, CA

9h • $150,000 - $215,000 • Hybrid

About The Position

DELFI Diagnostics, Inc. (DELFI Diagnostics) is developing next-generation, blood-based tests that are reliable, accessible and deliver a new way to help detect cancer. Employing advanced machine-learning methods to whole-genome sequencing data, the DELFI ("DNA EvaLuation of Fragments for early Interception") platform is built to address the highest-burden health challenges. DELFI Diagnostics prioritizes solutions that have the potential to save lives on a global scale, including for historically underserved populations. DELFI Diagnostics’ platform relies on fragmentomics – the discovery that cancer cells are more chaotic than normal cells and, when they die, leave behind tell-tale patterns and characteristics of cell-free DNA (cfDNA) fragments. FirstLook Lung, for individuals eligible for lung cancer screening, is DELFI Diagnostics’ first laboratory-developed screening test and can be part of routine blood work. FirstLook Lung uses millions of data points to reliably identify individuals who may have cancer detected through low-dose CT, including early stage disease with a negative predictive value of 99.8 percent. This test has not been cleared or approved by the FDA.

In our passionate pursuit to radically improve health outcomes, we serve humanity when we:

Lead with Science, Anchor in Pragmatism: We pioneer life-changing science by ensuring quality, transparency, and rigor at all times. We explore thoughtfully, experiment smartly, and deliver impact with conviction.

Build With & For All: We embrace diverse backgrounds to innovate and achieve together. We are not just building a product - we aim to disrupt the path of cancer for all - no matter geography or socioeconomic class

Put We over I: We are a home for high-performing people. Through teamwork, we build collective intelligence. Each of us wins when those we serve and those who serve with us--win. We show up with empathy, humility, and integrity at every step of the journey.

DELFI has 1-2 designated in-office working days each week for employees who live within within 50 miles of Palo Alto CA or Baltimore MD offices

We are entering a pivotal year at DELFI. With multiple key clinical study milestones on the horizon supporting our IVD submission, we need a Clinical Data Management (CDM) leader who can drive execution with precision and speed.

You will play a central leadership role in our key clinical validation studies. Whether leading a study end-to-end or driving critical data milestones for our regulatory submissions, you will hold high accountability for the integrity and timely delivery of our clinical data and key mentorship and oversight of junior team members. You’re a nimble problem solver who is willing to jump into any responsibility, from high-level strategy to query resolution. You are a highly skilled communicator with a deep understanding of how to navigate cross-functional relationships, driving progress towards shared goals.

This role sits within the Data Engineering function, a strategic choice that places Clinical Data Management directly adjacent to the technical tools that power our business. We are not looking for a software developer, but rather a Clinical Data Management expert who is eager to leverage a modern data stack (Databricks, SQL, R/Python). Alongside the Clinical Operations team, you will drive our clinical data operations, ensure audit-ready data quality for our regulatory submissions, and partner with our incoming Digital Health leadership to modernize how we capture, interpret and analyze patient data.

Requirements

• Clinical Trial Expertise: 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. You have led data management for multiple studies from protocol design to submission and have expert-level knowledge of Electronic Data Capture systems.
• Regulatory Depth: Expert knowledge of GCP, ICH, CDISC/SDTM. You have a deep understanding of what inspection-ready data looks like and how to deliver it.
• Technical Comfort: You are "Data Savvy." You may not be a software developer, but you are comfortable writing SQL to query a database and have exposure to R or Python for data review. You prefer a notebook environment over an Excel export.
• Execution Focus: You have a track record of hitting aggressive database lock timelines without compromising quality via strong cross-functional collaboration. You have partnered with and led CRO data management teams and understand how to partner with vendors to ensure high quality, on-time deliverables.

Nice To Haves

• IVD Experience: Direct experience with diagnostic studies and the unique challenges of linking biological sample data to clinical data.
• Oncology Experience: Familiarity with the oncology therapeutic area via clinical trials and/or biomarker studies.
• Startup Experience: Experience in lean, rapidly evolving environments and comfort owning a broad scope.
• Notebook & Markdown Experience: Familiarity with interactive coding environments (e.g., Jupyter, RMarkdown, Databricks) for reproducible data review and analysis.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed