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250232BRSenior Analyst - Database OperationJob Description1.Entry Level knowledge in Oracle Clinical and EDC systems like INFORM, RAVE etc. and also carries basic understanding of SDTM. 2.Work with the teams members to develop annotations for Governance approval of study specific nonstandard pages. 3.Support Quality of all new GMCS Library objects needed for clinical studies (DVGs, DVG subsets, Questions, Questions Sets and Question Groups, Validation, derivations) in a provisional state. 4.Support development, review and maintain global library copy groups of DCMs, DCIs, Procedures, Views, maintain Form Layout Templates, Extract Macros and Key Templates DCI books for reuse of standard pages for individual trials. 5.Ensure alignment between OC Global Library Objects and Metadata Repository. 6.Understanding Life Science Data Hub (LSH) structure and support GMCS projects from quality perspective. 7.For assigned GMCS clinical trials validate data load from multiple source systems (OC/ RDC, WDCS, Watson LIMS etc) into the data warehouse/ LSH and communicate with all affected parties, Quality Manager, Data Manager, Database Programmer, CRO/ CPO personnel and other Third Party vendors as needed. 8.Monitors study progress in different systems/ applicaitons from quality perspective for projects within GMCS. 9.Perform LSH set up GMCS studies.Minimum requirementsUniversity or college degree in life science, pharmacy, nursing statistics, biostatistics or equivalent relevant degree. Fluent English (oral and written). 1.Entry Level knowledge/ understanding and experience of applications like Oracle Clinical. 2.Ideally 5 plus or more years experience in drug development, with at least 4 year in Data Management activities. 3.Experience in managing outsourced studies or working for a CRO is desirable. 4.Thorough understanding of physiology, drug development process, clinical trial methodology, GCP, medical terminology, and coding. 5.Good organizational and project management skills. 6.Good technical and problem solving skills. 7.Ability to work independently, under pressure, demonstrating initiative and flexibility. 8.Attention to detail and quality focused. 9.Good interpersonal and communication skills and ability to operate effectively in an international environment.,
Keyskills :
basisaccountsresearchdatamanagementproblemsolvingclinicaltrialsdrugdevelopmentprojectmanagementcommunicationskillsustomerrelationsreptingthirdpartyvendacleclinicalmedicalterminology