Clinical Data Manager (CDM)Experience:5+ YearsEducation:Bachelor’s degree in Health/Clinical-related field or equivalentCertification:CCDM preferredRole SummaryResponsible forend-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 ofclinical data science, AI/ML, and analytics .Key ResponsibilitiesManage end-to-end CDM activities:Study Setup → Conduct → Database Lock/Closeout .Define specifications forProtocol Conversion, Database Build, CRF Design, Data Review, and Data Reconciliation .Manageexternal data integration, reconciliation, and data cleaningactivities.Develop and executedata cleaning strategies, query management, data review, and trending analysis .Perform holistic data review usingreporting, elluminate® Analytics, dashboards, KPIs, CTOA, and metricsto identify risks and drive mitigation.LeverageAI/ML for anomaly and outlier detectionto improve data quality and efficiency.Define specifications and collaborate with technical teams onelluminate® Data Centralconfiguration and data management workflows.Prepare and maintain CDM documentation includingDMP, CCGs, Help Text,



and DVSthroughout the study lifecycle.PerformQC/review of eCRFs, study documents, specifications, programs/reports, outputs, and elluminate® Data Central/Analytics modules .Ensure compliance withICH-GCP, 21 CFR Part 11, clinical trial methodology, applicable regulations, standards, and SOPs .Collaborate with study/project teams to ensuretimely, high-quality deliverables .Required Technical Skills5+ years of hands-on Clinical Data Management experience .Strong experience withEDC and Clinical Data Management Systems .End-to-end CDM lifecycle experience:Setup, Start, Conduct, and Closeout .Experience withCloud/SaaS platformspreferred.Experience withQlik, JReview, Spotfire, or similar data reporting/analytics tools preferred.Knowledge ofRBQM (Risk-Based Quality Management)methodology preferred.Exposure toCDISC standards and guidelines .Solid knowledge ofICH-GCP, 21 CFR Part 11, and clinical trial processes .Proficiency inMS Excel and MS Project .Professional SkillsStrongproject management, team leadership, planning, delegation, and problem-solvingskills.Stronganalytical and strategic thinking .Excellentcommunication, collaboration, prioritization, and organizational skills .Strong written and verbalEnglish communication .Preferred:CCDM Certification.

📌 Clinical Data Manager (Maharashtra)
🏢 vueverse.
📍 Maharashtra