FirstLook Lung is a blood-based test that helps identify lung cancer risk before or alongside LDCT, for USPSTF-eligible adults. From DELFI Diagnostics. Backed by Menlo.
About the role
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.
What they're looking for
- 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 a Statistical Analysis Plan and translate it into specification documents
More about this role
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.
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