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Senior Database Analyst-II

Secunderabad, Telangana
Job Code:
  • Biotechnology & Science
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Job Details

With guidance, provide technical information support to Clinical Science/Business Units Standards office to interpret data collection requirements into data models of low complexity and discuss with Novartis Clinical Data Standards Governance Board for input and approval. Develop and maintain all standard objects, procedures, templates and views for OC standard Global Library.With guidance, Work with the Clinical Science Units to understand the data requirements for collection and submission. With guidance, define the data content and structures for collection, transformation and CDISC SDTM submission requirements in Novartis Clinical Data Standards (NCDS) of low level of complexity. With guidance, work with the Data Standards Governance Board to ensure that the data models are consistent with Novartis Clinical Data Standards With guidance, perform Impact analysis for proposed modifications to existing domains, permitted choices for discussion with Governance. With guidance, develop, test and maintain all Global/Disease level Library objects needed for clinical studies (DVGs, DVG subsets, Questions, Questions Sets and Question Groups). Document, Develop, review and maintain Global Library Copy Groups of DCMs, DCIs, Procedures, Views and DCI books for reuse of standard pages for individual trials. Perform impact analysis for modifications to existing standard DCMs as well as effect on DCMs existing at the trial level. Need to work with external partners like CRO and Data Loaders and provide assistance with any technical information. With guidance, support senior/expert Global Librarians with the creation of metadata specifications that define the data content and structures for collection, transformation and CDISC SDTM submission requirements in Novartis Clinical Data Standards (NCDS). Incorporate newly discovered practices towards maintenance of the Global Library Conventions document for data modeling/.standards and Style Guide for OC/RDC implementation. Contribute to the review of global SOPs and business guidances/user guides directly impacting the function and providing input when applicable. Ensure alignment between OC Global Library Objects and Metadata Repository. Good Knowledge of Novartis Data Clinical Standards , Data Models and its implementation for database and GLIB development. Should be able to perform cross functional tasks ranging from Database builds, Database programming, GLIB tasks and LSH tasks activities on need by need basis and with availability of time bandwidth.. Subject matter expert in OC. Work with the CSU/BU for Novartis Clinical Data Standards and OC/RDC setup, including validation procedure development. Need to be proactive and start thinking of any process improvement during the day today activities.Timely and accurate development of standard data objects in the OC Global Library.Minimum requirementsUniversity or college degree in Life Sciences, Computer Science, Mathematics, Medical Informatics, Statistics, Public Health, Biology or equivalent degree (Minimum BS) Fluent English (oral and written). Minimum 4-5 years clinical database programming, setup of clinical databases and CRF design experience gained in the pharmaceutical industry or CRO as well as the following Good CDISC Understanding Implementation of CDISC Standards. Strong Understanding of clinical data management systems and/or relational databases as applied to clinical trials Input to requirements for eCRF Development. Strong knowledge of SQL or PL/SQL Development of validation and derivation procedures. Strong OC/RDC experience Development of objects in the OC global library. Attention to detail, quality, time management and customer focus Ability to translate technical concepts for non-technical users in the areas of CRF and validation procedure implementation in OC/RDC. Strong verbal and written communication skills to work with our global partners and customers
Additional Degree: B.Sc. (Science)

Experience: 4-5


Application Programming | Database Administration (DBA)
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