Clinical Data Manager / Senior Clinical Data Manager (Contract)

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Clinical Data ManagerLaboratory & Life Sciences

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Overview

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.

Technical Tools

Clinical Data ManagerLaboratory & Life Sciences

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:

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 a Statistical Analysis Plan and translate it into specification documents

Nice to Have

~1 min read

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

An equal opportunity employer

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.