Poornima Shreyas Kumar
#cdm# RBQM #central monitor#
- Role
- Expert, Clinical Data Quality, Centralized Monitoring at Merck Group
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Poornima Shreyas Kumar
15+ years of experience in clinical data management with strong knowledge of all the…
Experience
Expert, Clinical Data Quality, Centralized Monitoring
Oct 2021 — Present · IN
To support the setup of Clinical Data Review and Surveillance Tools (Centralized Quality Report (CQR) in Spotfire and Data Quality Surveillance Plan (DQSP)) and Cluepoints for KRIs and QTLs.Support the Project Data Manager and Trial Data Manager to define the Centralized Data Quality review strategy and risks to data quality.Perform Centralized Data Quality review activities and evaluate Data Quality and Integrity of study data as per the protocol, SOPs and Guidelines (Data outliers, Data trends, Data Integrity Issues andOther risk signals related to data).Monitor the findings of review and make recommendations for timely corrective actions and prevent actions (e.g, Data Validation Plan update, site education in collaboration with PDM and TDM.)Early identification of countries/site trends to support cross functional data driven decision (e.g, Site/country selection, enrollment improvement) Review of Database Setup Documentation, Data Management Plan, Data Validation plan eCRF Completion guidelines, UAT.Participating in continuous improvement activities, defining, and implementing the changes required to create an industry- leading centralized data quality review capability, including surveillance tools development, visualization review, data trend analysis, Risk based approach on data review.Perform the Quality Check on DQSP and CQR activities performed by peers and provide the feedback. Assists in developing and improving SOPs, Working Instructions and Best Practices. Provide mentoring to new Analyst.
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