Contract Clinical Data Manager (CDM) - DELFI Diagnostics
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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 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.
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 You'll Do
Core CDM Execution
- 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
Specification Development
- 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
What You'll Bring
Required (both levels)
- 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
Required (Senior level)
- 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
Preferred
- Experience in oncology, diagnostics, or IVD/regulated device studies
- R programming experience
- Familiarity with leveraging AI tools (e.g., Claude Code, Gemini) to streamline clinical data management workflows, data review, or scripting tasks
- Familiarity with Clario or comparable imaging/adjudication data platforms
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DELFI Diagnostics
View Company ProfileDELFI Diagnostics (operating at delfidiagnostics.com) is a pioneering biotechnology company specializing in early cancer detection through liquid biopsy technology. Founded as an American innovator, DELFI leverages AI, machine learning, and whole-genome sequencing to analyze DNA fragmentation patterns in blood—uncovering subtle signals that traditional methods miss. Unlike invasive procedures like biopsies, DELFI’s blood-based tests aim to identify cancer at its earliest, most treatable stages, particularly for high-risk patients. Under the hood, the platform deciphers genome-wide fragmentation profiles, a novel approach that transforms liquid blood samples into actionable diagnostic insights. This empowers clinicians to detect diseases like lung cancer with unprecedented sensitivity, enabling proactive interventions before symptoms manifest. Backed by a $225 million Series B financing round, DELFI is accelerating the development of a globally accessible portfolio of tests to redefine cancer screening.
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