Wajiha Khan
Senior Study Associate Oncology
- Role
- Senior Clinical Study Associate at Daiichi Sankyo US
- Location
- New York, NY, US
- LinkedIn followers
- 500 followers
About Wajiha Khan
Inspection management consultant with experience supporting global agency inspections & leading Inspections readiness activities. Core competency in inspection & audit readiness, risk- based quality management, CAPA development & implementation, response development for global agency inspections. Skilled project manager & communicator with experience supporting cross-functional teams, conducting internal audits, storyboard development support, and response development for inspection follow-ups. Trained and prepared sites for inspections post submissions. Proven technical skills in managing QMS Systems, database management, eTMF ownership, CTMS, Veeva vault, iMedidata RAVE EDC, Redcap & EPIC. Regulatory competency in 21 CFRs & ICH-GCP R2. Supported NCI, FDA, EMA, PMDA & CDC audits.
Experience
Senior Clinical Study Associate
Sep 2023 — Present
Education
University of Central Florida
Bachelors, Political Science and Philosophy
University of Maryland, Baltimore (UMB)
Master's degree, Nursing
2015 — 2016
The George Washington University School of Medicine and Health Sciences
Master of Science - MS, Clinical Research Administration
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