Senior Clinical Data Manager — Oncology Diagnostics

Socket.dev; United States; Remote; USD 55,000 - 110,000; Full time

Job summary

DELFI Diagnostics, Inc. is seeking an experienced Clinical Data Manager to provide contract CDM support during a critical validation program. The role emphasizes data cleaning, query management, and database lock readiness in a fast-paced environment.

The ideal candidate has 5+ years in CDM, with direct experience supporting database lock activities and proficiency in Medidata Rave EDC. Strong communication skills and the ability to work independently are essential.

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.
• Excellent written and verbal communication skills.

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 SAP.
• Provide limited statistical programming or implementation support for derived variables and TFL-related datasets, as skills allow.

Skills

CDM experience

Medidata Rave

Independent work

Documentation

Tools

Medidata Rave EDC

R programming

Clario

Job description

DELFI Diagnostics, Inc. is seeking an experienced Clinical Data Manager to provide contract CDM support during a critical validation program. The role emphasizes data cleaning, query management, and database lock readiness in a fast-paced environment.

The ideal candidate has 5+ years in CDM, with direct experience supporting database lock activities and proficiency in Medidata Rave EDC. Strong communication skills and the ability to work independently are essential.