Kumar Mahesh

Background

About Kumar Mahesh

My work summary I have worked as Database Designer/Technical Designer/Design Consultant and as Sr.Project Manager in various organisations I have been part of the study till it is pushed to production and later as part of migration activities too and in addition to this I was looking at high end review work/process deviations to document justification to audit which was Amgen CSI role to work few requests like using the standard SQL job code to run few reports for Audit purposes. I am flexible to go with which I am suitable with my experience till date on Medidata Rave for 10 plus years and in Central Designer less than 1 year. I have worked on AstraZeneca studies and also on the Global Library for close to 2 years when I was with IQVIA 1.I have around 9 to 10 years of study build tasks like eCRFs either at Architect or ALS method with Medidata Rave tool which is based upon CDISC standards. 2.I have worked as edit check programmer for close to 1 year, when I was with Accenture 3. I have worked as High end project data documents in compliance to external audit for 2 years (Amgen CSI role) running standard SQL reports for reconciliation purposes during study migrations (test and prod) environment 4.I have worked in Edit Check Specifications and various Data transfer specifications like Lab data, IVRS, Rave Safety Gateway. etc) 5.I have worked in Major Sponsor libraries like Oracle, Novartis, Britstol Meyers Squibb, Amgen and AstraZeneca. 6.I have worked on Data mapping specifications sponsor specific/SDTM standards 7.I have worked as QC as per situation that may demand with on job training 8. I had created training materials for DM team for testing eCRFs, Data entry for edit checks and for SAS outputs 9. I have worked in project management for 3 years for EDC edit check programmers and SAS checks teams and willing to learn programming either in Rave CF or SAS application. I am ready to join. Thanks and Regards, Dr. Kumar Mahesh 9912748408