Have an overall experience of 4+ years in clinical data management. I am well versed with all the processes and workflow of Clinical data management operations pertaining to both EDC and paper based clinical trials. I have sound knowledge and exposure to Clinical data management systems such as Medidata Rave 5.6 and Medical Affairs Rave 5.4, Oracle RDC 4.6.6.
Study Start-up: I have worked on Edit Check Test plan creation, Study specifications review and finalization as per protocol requirements, Edit checks Testing/Validation, Complete UAT plan creation and finalization, conduct UAT Strategy meeting with study team, UAT Summary reporting and finalization, Pre and Postproduction changes...