Having 10 yrs of experience in Clinical Research/Clinical ***** Management. Hands on experience in Clinical ***** Management Systems such as Oracle Clinical 4. 5, OC RDC, InForm, Medi ***** Rave and ClinTrial. Worked on Oncology, CNS, Endocrine, Opthalmology, Dermatology and Respiratory therapeutic areas for Phase I, II, III and IV trials. Excellent knowledge in CDISC SDTM, CDASH and ODM concepts. Proven track record in performing activities such as CRF design, ***** base design, ***** Management Plan preparation, Edit check specification, ***** entry, ***** validation, discrepancy management, query management, QC and QA activities by supporting ***** base lock. Working as a definer in Oracle LSH. Responsible for the ***** management delieverables, develop metrics, bid denfense, project management, business development, RFP/RFI response.