Clinical Data Manager, Senior

This is a fully remote position, open to applicants in United States.

📋 Description

• Execute continuous data cleansing and query management within the study EDC and data collection systems.

• Carry out data reviews, manage discrepancies, provide medical coding assistance as necessary, and engage in reconciliation activities, including aligning sample data with clinical data.

• Utilize data quality report outputs from DELFI's data team, converting findings into queries and solutions.

• Assist in preparation for CRF freeze/lock and database lock processes.

• Attend study team meetings and deliver concise weekly written status updates detailing completed work and any identified risks or blockers.

• Create and finalize specifications and documentation for Derived Variables using DELFI templates and standards.

• Aid in the development of specifications for Tables, Figures, and Listings, ensuring alignment with the Statistical Analysis Plan.

• Provide limited statistical programming or implementation assistance for derived variables and TFL-related datasets, depending on skill level.

⛳️ Requirements

• 3–5+ years of practical clinical data management experience within a pharmaceutical, medical device/diagnostic firm, or CRO.

• Direct experience in supporting database lock processes during clinical trials.

• Proficient in using Medidata Rave EDC.

• Capability to operate independently with minimal onboarding.

• Exceptional organizational, written, and verbal communication abilities.

• Senior level: 5+ years of CDM experience, including the development of DV and/or TFL specifications.

• Senior level: Competence in reading and interpreting a Statistical Analysis Plan and converting it into specification documents.

• Preferred: Background in oncology, diagnostics, or IVD/regulated device studies.

• Preferred: Experience with R programming.

• Preferred: Familiarity with utilizing AI tools like Claude Code or Gemini to enhance clinical data management processes, data reviews, or scripting tasks.

• Preferred: Experience with Clario or similar imaging/adjudication data platforms.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Flexible work arrangements to promote work-life balance.