Clinical Data Manager, Senior

Job not on LinkedIn

🔥 5 minutes ago

🇺🇸 United States – Remote

💵 $70 - $85 / hour

⏳ Contract/Temporary

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Delfi Diagnostics

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2018

🏥 Healthcare

🧬 Biotechnology

⚕️ Healthcare Insurance

💰 $225M Series B on 2022-07

Healthcare • Biotechnology • Healthcare Insurance

Delfi Diagnostics is a company dedicated to saving lives through early cancer detection using their innovative fragmentomics technology. Delfi has pioneered breakthroughs in machine learning and fragmentomics by analyzing cell-free DNA fragments from simple liquid biopsy blood samples to support early-stage cancer detection. Their scalable approach allows them to quickly scan millions of data points to identify previously unrecognized cancer-associated DNA fragments. Delfi Diagnostics collaborates with leading cancer biology, bioinformatics, and machine learning experts to advance their technology. The company has initiated a large-scale clinical trial, CASCADE-LUNG, to validate the effectiveness of its approach.

📋 Description

• 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 specifications and requirements documentation using DELFI templates and conventions • Support Table, Figure, and Listing specifications, including review against the Statistical Analysis Plan • Provide limited statistical programming or implementation support for derived variables and TFL-related datasets, as skills allow

🎯 Requirements

• 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 • Excellent organizational, written, and verbal communication skills • Senior level: 5+ years of CDM experience, including experience authoring DV and/or TFL specifications • Senior level: 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 • Preferred: R programming experience • Preferred: Familiarity with leveraging AI tools such as Claude Code or Gemini to streamline clinical data management workflows, data review, or scripting tasks • Preferred: Familiarity with Clario or comparable imaging/adjudication data platforms