01 Oct
|
vueverse.
|
Mumbai
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 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 Skills 5+ years of hands-on Clinical Data Management experience . Solid experience with
EDC and Clinical Data Management Systems . End-to-end CDM lifecycle experience:
Setup, Start, Conduct, and Closeout . Experience wit
📌 Clinical Data Manager (Mumbai)
🏢 vueverse.
📍 Mumbai