Summary
They work with members of the clinical data standards specialist to provide expert support ensuring the development, implementation and timely availability of consistent, high quality Clinical 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) and data transfer specifications
• Analysis data/TFL standards
• Associated standard metadata, business rules and guidelines.
About the Role
Lead multiple standards development activities across assigned Therapeutic Area (TA) For development of clinical data standards for assigned TA('s)
- Contribute towards Implementation of various assets
- Support with impact analysis or change management
- Ensure e2e standards development by following processes
- Ensure quality by performing peer review
- Ensure regulatory, system and quality requirements are met during the development
- Create/Review guidance and train stakeholders and drive adoption of developed standards
- Oversee process and quality adherence
- Monitor compliance and utilization, present metrics
- Collaborate with Governance, internal and external stakeholders for approval/endorsement
- As an SME provide expert opinion in matters relating to standards development.
- Support with internal and external audits
Lead 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
Accountable for overseeing & driving the efficient, high quality and timely implementation of new standards and/or updates to standards for:
Data Acquisition and Tabulation standards
- Standards in clinical systems including EDC, MDR and other global standards libraries including robust testing and validation
- Compliant data models to support the use and transformation of data acquisition, tabulation and review standards (including associated metadata).
- Use advanced database programming techniques to support the implementation of efficient data collection tools.
- Processes, tools and guidelines relating to the submission of standardized acquisition/tabulation data supporting regulatory submission.
Or/and;
Analysis and Reporting Data Standards
- Compliant analysis and reporting standards (ADaM and TFL)
- Use advanced programming knowledge to support specification of new analysis and reporting tools (incl. standard macros)
- Data models to support data analysis (ADaM) and reporting (TFL) standards (including associated metadata).
- Processes, tools and guidelines relating to the submission of standardized analysis data supporting regulatory submission.
Lead 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 maintain strong collaborative relationships with Data Operations, Biostatistics and Clinical Development groups supporting the development and use of Clinical Data Standards.
Lead and contribute to the development, maintenance and training of relevant clinical standards systems and processes.
Provide mentoring and technical guidance to Clinical Data Standards associates; Contributes to the effectiveness and development of talent.
Maintain 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.
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.
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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