delfidiagnostics - Clinical Data Manager / Senior Clinical Data Manager (Contract)

Remote - CT (Central)1w ago

Remote Senior NA Medical Devices Pharmaceuticals CRO Clinical Director Clinical Trials Contract Management Reporting CRO Gemini Claude Documentation Data Quality SAP

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, 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 • 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

Responsibilities

• 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