Sr. Global Librarian, Novartis
East Hanover, NJ
With general direction, provide timely
guidance to Clinical Science/Business Units Standards Office to
interpret data collection requirements into data models of moderate
complexity and discuss with Novartis Clinical Data Standards Governance
Board for input and approval. Independently develop and maintain all
standard objects, procedures, templates and views for OC standard Global
Library. Support or lead a special project (limited in scale and scope)
both clinical and non-clinical in nature.
- With general direction, work with the Clinical Science Units (CSUs) or Business Units (BUs) to understand the data requirements for collection and submission
- With general direction, define the data content and structures for collection, transformation and CDISC SDTM submission requirements in Novartis Clinical Data Standards (NCDS) of moderate level of complexity.
- With general direction, work with the Novartis Clinical Data Standards (NCDS) Governance Board to ensure that the data models are consistent with NCDS
- With general direction, perform impact analysis for proposed modifications to existing domains, permitted choices, and reference tables for discussion with NCDS Governance Board
- Independently 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 in individual trials
- Seek process improvement and incorporation of newly discovered practices towards maintenance of Global Conventions for data modeling/standards and Style Guide for OC/RDC implementation
- Contribute to the review of global SOPs and business guidance’s/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 Global/CSU/BU standards
- Maintain Form Layout Templates, Extract Macros and Key Templates for use in individual trials
- Promote study DCM, DCIs and Procedures to the GLIB if approved for re-use by NCDS Governance Board
- Ensure alignment between OC Global Library Objects and Metadata Repository.
- Good Knowledge of Novartis Data Clinical Standards , Data Models and their implementation for database and GLIB development
- Train less experienced associates on specific tasks relating to Novartis Clinical Data Standards and/or Global Library Processes
- Subject matter expert in OC and GLIB processes
- Act as a consultant to CSU/BU for Novartis Clinical Data Standards and OC/RDC setup, including validation procedure development Minimum requirements Education and/or professional experience: University or college degree in Life Sciences, Computer Science, Mathematics, Medical Informatics, Statistics, Public Health, Biology or equivalent degree (Minimum BS)
Experience / Professional Requirements: Minimum 3 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.
See: http://www.indeed.com/viewjob?jk=475f444b86bd0704
