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