Division Pharma
Business Unit Pharma - Global Development
Country USA
Work Location East Hanover, NJ
Company/Legal Entity USA Novartis Pharmaceuticals Corporation, East Hanover, NJ
Functional Area Development & Medical
Job Type Full Time
Employment Type Permanent
Job Description May assist manager in coordinating and directing Global Library/Modelling activites in support for timely development of standards and study level objects with highest quality to facilitate efficient trial setup. Independently provide timely guidance to Clinical Science/Business Units Standards Office to interpret data collection requirements into data models of high 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. Translate disease area knowledge into both data modeling and technical solutions in order to meet the needs of the franchise/business unit. Manage internal and external relationships. Support or lead a special project (strategic, larger in scale and scope) both clinical and non-clinical in nature.
•Provide disease area knowledge and data model/technical expertise in the establishment of data standards. Collaborate with Clinical Standards Office and Novartis Clinical Data Standards (NCDS) Governance in design, development and implementation of data models and metadata for new or changed standard pages (Global and CSU/BUs-specific) for collection and submission
•Independently define the data content and structures for collection, transformation and CDISC SDTM submission requirements in Novartis Clinical Data Standards (NCDS) of high level of complexity
•Independently work with the NCDS Governance Board to ensure that the data models are consistent with Novartis Clinical Data Standards
•Independently 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
•Evaluate proposed process improvement, performing feasibility assessment prior to incorporation into the Global Conventions for data modeling/standards and Style Guide for OC/RDC implementation
•Responsible for authoring global SOPs and business guidances/user guides directly impacting the function and for reviewing and providing input to SOPs and BGs when applicable
•Document, develop, test and maintain OC validations and derivations procedures using PL/SQL or SQL on Global/CSU/BU standards
•QC revised Form Layout Templates, Extract Macros and Key Templates for use in individual trials prior to production release
•Perform impact analysis for modifications to existing standard DCMs as well as effect on DCMs existing at the trial level
•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
•Strong Knowledge of Novartis Data Clinical Standards including disease areas/BUs , data models and their implementation for database and GLIB development
•Train, coach or mentor less experienced associates relating to OC, Novartis Data Standards and/or Global Library processes
•Subject matter expert in Data Modeling including disease area(s)/BUs, OC and Glib processes
•Act as a consultant to CSU/BU for Novartis Clinical Data Standards, Data Modeling and OC/RDC setup, including validation procedure development
•Supervise the work of less experienced associates; may deputize as necessary for supervisor
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 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:
•Strong 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
•Expert in OC/RDC 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 Novartis Clinical Data Standards, Data Modeling, CRF and validation procedure implementation in OC/RDC
•Strong verbal and written communication skills to work with our global partners and customers
See: https://sjobs.brassring.com/2057/ASP/TG/cim_jobdetail.asp?jobId=1408996&partnerid=13617&siteid=5260&codes=IND
