Lead Principal CDS Specialist

• Data collection tools in EDC (CRFs, edits checks, derivations, core configurations) and data transfer specifications
• Analysis data/TFL standards
• Associated standard metadata, business rules and guidelines.

Lead multiple standards development activities across assigned Therapeutic Area (TA) For development of clinical data standards for assigned TA(s)

• nContribute towards Implementation of various assets
• nSupport with impact analysis or change management
• nEnsure e2e standards development by following processes
• nEnsure quality by performing peer review
• nEnsure regulatory, system and quality requirements are met during the development
• nCreate/Review guidance and train stakeholders and drive adoption of developed standards
• nOversee process and quality adherence
• nMonitor compliance and utilization, present metrics
• nCollaborate with Governance, internal and external stakeholders for approval/endorsement
• nAs an SME provide expert opinion in matters relating to standards development.
• nSupport with internal and external audits

nLead or Represent CDS in special projects (Non Drug Projects) and improvement initiatives as part of functional or wider Novartis initiatives and ensure smooth execution. Accountable for analyzing metric related to standards adoption and present the same to leadership and governance boards

nAccountable for overseeing & driving the efficient, high quality and timely implementation of new standards and/or updates to standards for:

nData Acquisition and Tabulation standards

• nStandards in clinical systems including EDC, MDR and other global standards libraries including robust testing and validation
• nCompliant data models to support the use and transformation of data acquisition, tabulation and review standards (including associated metadata).
• nUse advanced database programming techniques to support the implementation of efficient data collection tools.
• nProcesses, tools and guidelines relating to the submission of standardized acquisition/tabulation data supporting regulatory submission.

nOr/and;

nAnalysis and Reporting Data Standards

• nCompliant analysis and reporting standards (ADaM and TFL)
• nUse advanced programming knowledge to support specification of new analysis and reporting tools (incl. standard macros)
• nData models to support data analysis (ADaM) and reporting (TFL) standards (including associated metadata).
• nProcesses, tools and guidelines relating to the submission of standardized analysis data supporting regulatory submission.

nLead the technical review and assessment of industry and regulatory standards and guidelines supporting regular gap/impact analysis and implementation of action plans where needed.

nCommunicate effectively with the partners and customers; Establish and maintain strong collaborative relationships with Data Operations, Biostatistics and Clinical Development groups supporting the development and use of Clinical Data Standards.

nLead and contribute to the development, maintenance and training of relevant clinical standards systems and processes.

nProvide mentoring and technical guidance to Clinical Data Standards associates; Contributes to the effectiveness and development of talent.

nMaintain up-to-date, advanced knowledge of relevant technologies (EDC, software languages, applications etc.), Industry Standards (e.g. CDISC, define.xml, eCTD etc.) and regulatory guidelines.

nRepresent 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.

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