Clinical Data Manager​/Senior Clinical Data Manager

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 is approaching a series of time-critical milestones for the DELFI-L201 (CASCADE) IVD Clinical Validation study. We are seeking an experienced contract Clinical Data Manager (CDM) to provide supplemental CDM capacity through this critical period.

• Perform ongoing data cleaning and query management in the study EDC and data collection systems

• Conduct data review, discrepancy management, medical coding support (as needed), and reconciliation activities, including sample-to-clinical data reconciliation

• Work from data quality report output produced by DELFI’s data team, translating findings into queries and resolutions

• Support CRF freeze/lock readiness and database lock preparation

• Participate in study team meetings and provide brief weekly written status summaries covering work completed and risks/blockers

• Develop and finalize Derived Variable (DV) specifications and requirements documentation using DELFI templates and conventions

• Support Table, Figure, and Listing (TFL) specifications, including review against the Statistical Analysis Plan (SAP)

• Provide limited statistical programming or implementation support for derived variables and TFL-related datasets, as skills allow

• 3–5+ years of hands-on clinical data management experience in a pharmaceutical, medical device/diagnostic company, or CRO

• Direct experience supporting database lock activities in clinical trials

• Proficiency with Medidata Rave EDC

• Ability to work independently with minimal ramp-up, and excellent organizational, written, and verbal communication skills

• 5+ years of CDM experience, including experience authoring DV and/or TFL specifications

• Ability to read and interpret…