01 Oct
|
vueverse.
|
Bengaluru
01 Oct
vueverse.
Bengaluru
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 e CRFs, 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. Robust experience with EDC and Clinical Data Management Systems. End-to-end CDM lifecycle experience: Setup, Start, Conduct, and Closeout. Experience with Cloud/Saa S platforms preferred.
📌 Clinical Data Manager (Bengaluru)
🏢 vueverse.
📍 Bengaluru