Clinical Data Manager (CDM)Experience: 5+ YearsEducation: Bachelor’s degree in Health/Clinical-related field or equivalentCertification: CCDM preferredRole SummaryResponsible 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 ResponsibilitiesManage 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 Skills5+ 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 SkillsStrong project management, team leadership, planning, delegation, and problem-solving skills.Robust analytical and strategic thinking .Excellent communication, collaboration, prioritization, and organizational skills .Strong written and verbal English communication .Preferred: CCDM Certification.

📌 Clinical Data Manager (Vasanth Nagar)
🏢 vueverse.
📍 Vasanth Nagar