Clinical Data Manager / Senior Clinical Data Manager (Contract)

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

Actual base pay will consider experience, skillset, and education.