ThePrincipalClinicalDataStandards Specialistis responsiblefor the development, maintenance and implementation of Industry (CDISC and regulatory) compliant Clinical Data Standards, providing expert support tobusinessusers and teams on their usein line withthe Clinical Data Standardsstrategy.
They provideexpertsupport ensuringthe development, implementation and timely availability ofconsistent, high qualityClinical Data Standards deliverables supporting the acquisition and tabulation and/or analysis and reporting of Clinical Trial data across global libraries including;
Data collection tools in EDC (CRFs, edits checks, derivations, core configurations) anddata transfer specifications
Analysis data/TFL standards
Associated standard metadata, business rules and guidelines.
Lead and contributetoClinical Data Standardsdefinition, development, validation and support within assigned standards discipline(domain)including the development and maintenance of associated metadata, documents, business rules andguidelines where applicable.
Define and deliver to robust, priority driven standards development plans for assigned area to ensure agreed deliverables are met and assigned resources are fully and effectively utilized.
Responsible for driving theefficient, high quality and timelyimplementation of new standardsand/orupdates to standardsfor:
Data Acquisition and Tabulation standards
Standards in clinical systems including EDC, MDR and other global standards librariesincludingrobust testing and validation
Compliantdata models to supportthe use and transformation ofdata acquisition, tabulation and reviewstandards(including associated metadata).
Useadvanced database programming techniques tosupport the implementation of efficient data collection tools.
Processes, tools and guidelines relating to thesubmissionof standardizedacquisition/tabulation data supporting regulatory submission.
Analysis and Reporting Data Standards
Compliantanalysisand reportingstandards(ADaM and TFL)
Useadvanced programming knowledge to support specification ofnew analysisandreporting tools (incl. standard macros)
Data models to support dataanalysis (ADaM) and reporting (TFL)standards(including associated metadata).
Processes, tools and guidelines relating to thesubmissionof standardized analysis data supporting regulatory submission.
In collaboration with representatives across Data Operations disciplines and key stakeholder and partner functions within GDO and across Global Drug Development,ensurethe accurate translation of scientific and analytical requirements into efficient, compliant standards.
Support and ensure the appropriate and efficientgovernanceand approval of global and project/study specific clinical data standardsliaisingwith governance boards as needed.
Contribute to the technical review and assessment of industry and regulatory standards and guidelines supporting regular gap/impact analysis and implementation of action plans where needed.
Communicate effectively with the partners and customers; Establish and maintainstrongcollaborativerelationships withData Operations, Biostatistics and Clinical Development groupssupporting the development and use of Clinical Data Standards.
Lead and contribute to thedevelopment, maintenance andtraining of relevant clinical standardssystems and processes.
Act as an expertconsultantproviding Clinical Data Standards input to all relevantareasincluding; electronic data capture/database programming, edit check programming, report programming, electronic data loads, IVR technology, electronic patient reported outcomes, metadata management and/or other clinical data management or analysis data and TFL-related systems.
Actassubject matter expert (SME) for assigned area providing support,consultationand training to end users and SME networks on implementation of standards and related tools ondevelopment programs.
Provide mentoring and technical guidance to Clinical Data Standards associates.
Maintain up-to-date, expert knowledge of relevant technologies (EDC, software languages, applications etc.), Industry Standards (e.g. CDISC, define.xml, eCTD etc.) and regulatory guidelines.
May represent Novartis within industry wide associations and working groups; contributing to regulatory guidelines, industry practices and professional standards development organizations such as CDISC, CFAST, PhUSE CSS, DIA etc.
As needed, act as a Clinical Standards representative supporting data standards governance, process improvement initiatives and/or other non-clinical projects.
Key Performance Indicators
Achieve overall goals as set each year by Group Head Clinical Standards.
Achieve high level of quality, timeliness and customer satisfaction onClinical Data Standards activities anddeliverables.
Achieve high levels ofeffective collaboration,customer satisfaction on support and training provided within discipline/area.
Achieveminimal number of post-production changes resulting fromClinical Data Standardsissues.
No critical findings as result of routine audits or health authority inspections relating to activities/deliverables supported by the Clinical Standards Group.
Impact on the organization:
Contribution to timely availability ofefficient, complaint and high quality Clinical Standards used across Global Drug Development.
Contribution to external quality reputation of Novartis (Clinical sites and regulators).
Support/training for end usersonefficient implementation of reporting data standards.
BS/BA/MS in computer science,management information systems,health sciences, statistics, or related field.
Fluent English (oral and written).
At least 6 years industry experience in one of the following fields;
EDC development and implementation preferably using Medidata-Rave
Statistical Programming using SAS and CDISC data standards
Strong knowledge in one or more area of industry data standards and requirements including data acquisition, CDISC (CDASH, SDTM, ADaM), reporting and analysis, regulatory data submission.
Experience in supporting development of clinical standards and associated guidelines.
Experttechnical skills relevant to;
Data Acquisition and Tabulation
Good knowledge of EDC systems (preferably including Medidata-Rave)
Good knowledge in Object Oriented Programming concepts
Knowledge of other programming languages such as Visual Basic, SQL-PL/SQL and C# or Javapreferable
Data Analysis and reporting
Goodknowledge of SAS and other statisticalprogramming languages/software (e.g. R)
Good understanding ofstatistical programming/statistical concepts in clinical trials
Knowledge of other programming languages such as Visual Basic, SQL-PL/SQL, XML,Pythonpreferable
Strongunderstanding and knowledge of regulatory requirements and industry standards relevant to data management and statistical programming (including GCP, ICH)
Good project management and coordinationskills;Strongproblem-solving, negotiation and conflict resolution skills.
Outstandinginterpersonal and written and oral communication skills, with the ability to effectively communicate cross-functionally.
Strongunderstanding of drug development, global clinical trial / project practices, procedures, methodologies.
Proven ability to provide and coordinate internal and external training(Experience working in highly matrix teams and providing technical guidance).
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.