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 clinical database management system (such as OC / RDC, Inform, Rave) using relevant programming languages (SQL, PL / SQL, C #, VB script, SAS).
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 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 Data Standards Governance Board to ensure that the data models are consistent with Novartis Clinical Data Standards
With general direction, Perform Impact analysis for proposed modifications to existing domains, permitted choices for discussion with Governance.
Independently, develop, test and maintain all Global / Disease level Library objects needed for clinical studies (DVGs, DVG subsets, Questions, Questions Sets and Question Groups) or equivalent in CDMS.
Document, Develop, review and maintain Global Library Copy Groups of DCMs, DCIs, Procedures, Views and DCI books or equivalent in CDMS for reuse of standard pages for individual trials.
Seek process improvement and incorporation of newly discovered practices towards maintenance of Global Conventions for data modeling / standards and Style Guide for CDMS implementation.
Contribute to the review of global SOPs and business guidance / user guides directly impacting the function and providing input when applicable.
Document, Develop, test and maintain OC validations and derivations procedures using (SQL, PL / SQL, C #, VB script, SAS) on Global / CSU / BU standards.
Maintain Form Layout Templates, Extract Macros and Key Templates or equivalent for use in individual trials.
Promote study DCM, DCIs and Procedures to the GLIB or equivalent if approved for re-use by Governance.
Ensure alignment between CDMS 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,INFORM and GLIB processes
Act as a consultant to CSU / BU for Novartis Clinical Data Standards and CDMS setup, including procedure development or equivalent.
With general Direction, Manage MDR related Tasks ensuring consistency across consuming systems (such CDMS, LSH).
University or college degree in Life Sciences, Mathematics, Computer Science, Medical Informatics, or equivalent degree Fluent English (Oral and Written) Ideally 6 years’ experience in Drug Development with at least 5 years' in Clinical Database Development