Senior Clinical Data Manager

About Us

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 Eva Luation 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. First Look Lung, for individuals eligible for lung cancer screening, is DELFI Diagnostics’ first laboratory-developed screening test and can be part of routine blood work. First Look 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 50 miles of Palo Alto CA or Baltimore MD offices

We are entering a pivotal year h 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.

• 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…