Sulagna Basu
Sr. Manager, clinical Data Management at Bristol Myers Squibb
- Role
- Sr Clinical Data Manager at Gilead Sciences
- Location
- Bellevue, WA, US
- LinkedIn followers
- 500 followers
About Sulagna Basu
CLINICAL DATA MANAGERClinical Data Manager on for various CRO and working on different projects.Participates in the review of Clinical research documents (e.g. Protocols, Case Report Forms [CRFs], Design Validation Plan)Develops Data Management Plan (DMP), maintains DMP throughout study project lifecycle and ensures DMP is followed according to study design and requirementsDevelops clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations. Maintenance/tracking of Electronic Data Capture (EDC) user management and other clinical databases across assigned studies, including but not limited to, compiling master user lists and activating/deactivating user accounts.Assist in defining and /or create data listings, summary tables, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock.Troubleshoot with the issues logged by Monitors in electronic data captureCreation of a medical dictionary and the datasets
Experience
Sr Clinical Data Manager
Jan 2017 — Present
Education
St. Joseph's School
XII, Science
1985 — 2000
Skills
- Ich-Gcp
- Clinical Data Management
- Oracle Clinical
- Clinical Trials
- Sop
- Inform
- Cdisc
- Protocol
- Pharmacovigilance
- Edc
- Ctms
- Oracle
- CRO
- Data Management
- 21 Cfr Part 11
- Clinical Research
- Gcp
- Data Validation
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