Clinical Data Manager / Senior Clinical Data Manager (Contract)

DELFI Diagnostics develops blood-based cancer detection tests using advanced machine-learning methods applied to whole-genome sequencing data. The contract Clinical Data Manager or Senior Clinical Data Manager will provide supplemental clinical data management capacity for the DELFI-L201 (CASCADE) IVD Clinical Validation study, focusing on data cleaning, query management, reconciliation, database lock readiness, and specification development.

Responsibilities

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

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

Oncology experience

Diagnostics experience

IVD studies

Regulated device studies

R programming

AI tool utilization

Data review

Scripting

Clario platform

Imaging data platforms

Adjudication data platforms

Company

Blood-based cancer detection using AI and whole-genome sequencing

Palo Alto, California, USA

https://delfidiagnostics.com/

Founded in 2019

51-200 employees

Qualifications

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

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

Required skills

Clinical Data Management, Clinical Trial Database Lock, Medidata Rave EDC, Derived Variable Specifications, Table, Figure, and Listing (TFL) Specifications, Statistical Analysis Plan Interpretation, Medical Coding, R Programming, Oncology/Diagnostics Clinical Studies, Clario Imaging/Adjudication Data Platforms

Preferred skills

R programming experience, Palo Alto, California, USA, https://delfidiagnostics.com, H1B Sponsorship, Data Powered by, Distribution of Different Job Fields Receiving Sponsorship, 75, Represents job field similar to this job, Engineering and Development, Accounting and Finance, Trends of Total Sponsorships, *2026, (2), 2025, 2024, (1), 2023, (4), 2022, 2021, Growth Stage, Total Funding, $331.57M, Key Investors, DFJ Growth, OrbiMed, Menlo Ventures, 2022-07-18, Series B· $225M, 2021-01-12

Experience

3+ years