Sandip K N.
Senior Clinical Data Manager @Bristol Myers Squibb
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WORK HISTORY
Senior Clinical Data Manager @Bristol Myers Squibb
Therapeutic Area- Hematology_Oncology & Oncology, Immunogenecity. NeuroscienceSet-Up PhaseCreate or revise Data Validation Specifications (DVS).Create or revisw Data Base Specification.(DB Spec)Develop and test Rave eCRF Completion Instructions (CCI).Prepare detailed specifications for reports, including SAS Listing Specifications.Perform Acceptance Testing (AT) for eCRFs and User Acceptance Testing (UAT) for reports.Conduct testing of edit checks and dynamic checks.Perform TSDV, Safety Mapping, SMILE activity.Conduct PhaseGenerate query management reports and allocate or resolve queries.Produce data validation and data review reports.Validate data through reports and review outputs of data review reports.Perform third-party data reconciliation, including:PK ReconciliationECG ReconciliationIRT ReconciliationExecute SAE reconciliation.Upload documents to the respective eTMF placeholders on a monthly basis.Manage responsibilities for any post-production changes, following retro-planning procedures.P21 report reviewClose-Out PhaseCreate Clean Patient Tracker (CPT).Share study metrics as per the defined schedule.Locking, freezing. eCRF Archiving.
EDUCATION
Rajiv Gandhi University of Health Sciences
Bachelor of Pharmacy - BPharm, Pharmacy
ABOUT SANDIP K N.
Dynamic and proactive Clinical Data Manager with over 7 years of experience in Clinical Research, combining strong academic knowledge with extensive industry exposure. Known for effective analytical ability and a creative, solution-oriented mindset.I thrive on tackling new challenges and meeting diverse deliverable timelines while maintaining the highest standards of quality. My passion for Clinical Data Management has consistently translated into impactful results for clients. For example, I successfully implemented SAS programming automation for a critical task, reducing turnaround time from 3–4 days to just 2–3 hours—earning client appreciation and recognition.Rewarded alongside my team for achieving ambitious deliverables within tight timelines, I bring expertise across all phases of Data Management—from Study Set-Up through Conduct and Close-Out. Beyond technical proficiency, I excel in resource management and fostering collaboration.Passionate about advancing Clinical Research and contributing to innovative therapies, I continuously enhance my skills through diverse tasks and learning opportunities.
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