Global Librarian @ Novartis - Hyderabad, Andhra Pradesh

With general direction, develop and maintain all standard objects, procedures, templates and views for OC standard Global Library. With guidance, translate data models into metadata specifications for inclusion into the MDR. With general direction begin to assist senior/expert global librarians in the interpretation of data collection requirements and the creation of data models of low to moderate complexity. Support a special project (limited in scale and scope) both clinical and non-clinical in nature.
•With general direction , work with other global librarians to understand the data requirements for collection and submission
•With general direction, work with the Data Standards Governance Board, other global librarians and/or members of the metadata team to discuss technical issues with implementation of approved OC data structures.
•With general direction, perform Impact analysis for proposed modifications to existing domains, permitted choices for discussion with Governance.
•With general direction, develop, and test all new Global/Disease level Library objects needed for clinical studies (DVGs, DVG subsets, Questions, Questions Sets and Question Groups) in a provisional state.
•With general direction, 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.
•Recommend newly discovered practices for consideration towards the 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.
•Document, develop, test and maintain OC validations and derivations procedures using PL/SQL or SQL on cross-CSU/BU and CSU-/BU-specific standards.
•With general direction, maintain Form Layout Templates, Extract Macros and Key Templates for use in individual trials.
•With general direction, 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).
•With general direction, recommend the promotion of study DCM, DCIs and Procedures to the GLIB if approved for re-use by Governance.
•With general direction, 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
•Subject matter expert in OC.
•Work with the CSU/BU for Novartis Clinical Data Standards and OC/RDC setup, including validation procedure development.
Minimum requirements
University 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 2 years clinical database programming, setup of clinical databases and CRF design experience gained in the pharmaceutical industry or CRO as well as the following:
•Basic CDISC Understanding: Implementation of CDISC Standards.
•Good Understanding of clinical data management systems and/or relational databases as applied to clinical trials: Input to requirements for eCRF Development.
•Good knowledge of SQL or PL/SQL: Development of validation and derivation procedures.
•Strong OC/RDC experience: including the 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.