Karishma Rakhangi User
@karishmarakhangiuser
Associate Manager in clinical data management with 10+ years driving EDC trials, DQST, SDV, and eTMF QC.
IndiaWhat I'm looking for
I’m currently an Associate Manager at Bristol Meyers Squibb, leading multiple studies (2 studies and 1 as Back up AM). I coordinate clinical data management workstreams to ensure smooth execution of key milestones and study timelines.
With 10+ years of experience, I’m well versed with the processes and workflow of clinical data management operations. I bring strong technical knowledge of CDM in startup and conduct, and I have worked on EDC-based clinical trials using systems including Rave, Oracle Clinical, RDC 4.6, CDW, and TDHR.
On my current studies, I prepare and present DQST and global team updates with complete data management status, monitor and communicate query and discrepancy health, and escalate progress where needed. I support activities such as Freeze/Lock form status, Uncoding terms, pending SDV/PI sign, SAE reconciliation, subject status, PDRP review, unlock/unfreeze requests, training and mentoring, and ensuring TMF filing and eTMF QC are up to date.
Previously, I strengthened my foundation across data quality and review work: reconciliation and resolution of discrepancies, manual/critical listing reviews, edit checks, SAS listing review and validation, eCRF completion instruction updates, QC peer reviewing, metrics for missing pages and query backlog, and eTMF share portal uploads. I’m flexible, adapt to change quickly, and work independently while partnering with multi-disciplinary teams.
Experience
Work history, roles, and key accomplishments
Lead multiple clinical studies (2 studies and 1 as Back-up AM) and drive end-to-end clinical data management activities through key milestones including Migration, Final DBL, CPG, and Interim Analysis. Own study status reporting, query and SDV tracking, eTMF QC, training/mentoring, and site closure deliverables.
Senior Clinical Data Analyst
Symbiance
Feb 2022 - Aug 2024 (2 years 6 months)
Performed clinical data management work for EDC-based trials, including review and resolution of discrepancies across listings and reconciliations. Supported study timelines and data lock/freeze deliverables through SAS listing review and validation workflows.
Clinical Data Co-ordinator II
Quartesian
Feb 2021 - Feb 2022 (1 year)
Supported clinical data management operations including eCRF completion instruction updates and adherence to protocol amendment-driven documentation changes. Contributed to edit check test data entry/validation and ongoing QC activities.
Executed clinical reconciliation activities (SAE, ePRO, IVRS, CCLS, ECG/PFT, and lab data) and supported manual and external data review. Helped maintain study metrics for missing pages, query backlog, SDV pending, and overall coding/status reporting.
Managed clinical data management process support across EDC trial activities, including timelines for database lock/freeze, interim analysis, and DMC-related milestones. Participated in SAS listing reviews and validation aligned to test plans for specific Rave-based studies.
Performed data analysis and support tasks for clinical data management operations, including ongoing QC and reconciliation-related activities. Assisted with documentation and workflow execution for clinical trial data processing.
Education
Degrees, certifications, and relevant coursework
Allana College Pune
Master of Pharmacy, Pharmacy
Completed a Master of Pharmacy program at Allana College in Pune.
Tatyasaheb Kore College of Pharmacy, Kolhapur
Bachelor of Pharmacy, Pharmacy
Completed a Bachelor of Pharmacy degree at Tatyasaheb Kore College of Pharmacy in Kolhapur.
Availability
Location
IndiaAuthorized to work in
Job categories
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