We are looking for an independent, results-driven Clinical Data Manager (CDM) to serve as a platform expert across our clinical trial lifecycle. In this role, you will leverage cutting-edge SaaS platforms—including elluminate®—and AI/ML tools to perform continuous data analytics, streamline data cleaning strategies, and deliver high-quality datasets to sponsors.

Responsibilities:
• Database & Study Setup: Define project specifications for Data Management services, including eCRF design, database build, protocol conversion, and data reconciliation tool specifications.
• Advanced Data Cleaning & AI Integration: Execute proactive data cleaning strategies, utilizing artificial intelligence (AI) and machine learning (ML) for anomaly/outlier detection to optimize trial data quality and delivery speed.
• Analytics & Trending: Conduct holistic data reviews and trend analyses via elluminate Data Central and operational dashboards to proactively identify trial risks and implement mitigation strategies.
• Documentation & Oversight: Draft and maintain essential CDM documentation (DMP, CCGs, DVS, Help Text) throughout the trial lifecycle while running QC checks across eCRFs, reports, and team deliverables.
• Metrics & KPI Monitoring:



Interpret Clinical Trial Operational Analytics (CTOA) to provide actionable insights and strategic recommendations to project leads.
• External Data Management: Oversee the integration, cleaning, and reconciliation of external data sources to ensure trial-wide accuracy.
• Compliance & Standards: Maintain strict adherence to ICH/GCP, 21 CFR Part 11, and company quality procedures.

Requirements:
• 5+ years of progressive experience in Clinical Data Management.
• Bachelor’s degree in a health-related field, life sciences, or equivalent practical experience.
• CCDM® (Certified Clinical Data Manager) certification is highly preferred.
• Robust proficiency with EDC platforms and Clinical Data Management Systems (CDMS).
• Hands-on experience or familiarity with Cloud SaaS platforms and specialized data analytics/visualization tools (e.g., elluminate, Spotfire, Qlik, JReview).
• Knowledge of CDISC guidelines and Risk-Based Quality Management (RBQM) methodologies.
• In-depth understanding of regulatory guidelines (ICH/GCP, 21 CFR Part 11).
• Advanced proficiency in MS Office (MS Project, MS Excel).

📌 Clinical Data Manager (Bengaluru)
🏢 Trigent Software
📍 Bengaluru