Clinical Data Manager

Clinical Data Manager (CDM)

Experience: 5+ Years

Education: Bachelor’s degree in Health/Clinical-related field or equivalent

Certification: CCDM preferred

Role Summary

Responsible for end-to-end Clinical Data Management (CDM) activities across study setup, conduct, and closeout, including database design/build, data cleaning, reconciliation, validation, reporting, and delivery of high-quality clinical trial data. Acts as a platform expert and supports the adoption of clinical data science, AI/ML, and analytics.

Key Responsibilities

• Manage end-to-end CDM activities: Study Setup → Conduct → Database Lock/Closeout.
• Define specifications for Protocol Conversion, Database Build, CRF Design, Data Review, and Data Reconciliation.
• Manage external data integration, reconciliation, and data cleaning activities.
• Develop and execute data cleaning strategies, query management, data review, and trending analysis.
• Perform holistic data review using reporting, elluminate® Analytics, dashboards, KPIs, CTOA, and metrics to identify risks and drive mitigation.
• Leverage AI/ML for anomaly and outlier detection to improve data quality and efficiency.
• Define specifications and collaborate with technical teams on elluminate® Data Central configuration and data management workflows.
• Prepare and maintain CDM documentation including DMP, CCGs, Help Text, and DVS throughout the study lifecycle.
• Perform QC/review of eCRFs, study documents, specifications, programs/reports, outputs, and elluminate® Data Central/Analytics modules.
• Ensure compliance with ICH-GCP, 21 CFR Part 11, clinical trial methodology, applicable regulations, standards, and SOPs.
• Collaborate with study/project teams to ensure timely, high-quality deliverables.

Required Technical Skills

• 5+ years of hands-on Clinical Data Management experience.
• Strong experience with EDC and Clinical Data Management Systems.
• End-to-end CDM lifecycle experience: Setup, Start, Conduct, and Closeout.
• Experience with Cloud/SaaS platforms preferred.
• Experience with Qlik, JReview, Spotfire, or similar data reporting/analytics tools preferred.
• Knowledge of RBQM (Risk-Based Quality Management) methodology preferred.
• Exposure to CDISC standards and guidelines.
• Strong knowledge of ICH-GCP, 21 CFR Part 11, and clinical trial processes.
• Proficiency in MS Excel and MS Project.

Professional Skills

• Strong project management, team leadership, planning, delegation, and problem-solving skills.
• Strong analytical and strategic thinking.
• Excellent communication, collaboration, prioritization, and organizational skills.
• Strong written and verbal English communication.

Preferred: CCDM Certification.