Clinical Data Manager (CDM)

nExperience: 5+ Years

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

nCertification: CCDM preferred

nRole Summary

nResponsible 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.

nKey Responsibilities

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

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

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

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