393392BR
Apr 10, 2024
India
About the Role
Your responsibilities include, but are not limited to:
• Lead and contribute to Clinical Data Standards planning, definition, development, validation and support within assigned standards discipline (domain) including the development and maintenance of associated metadata, documents, business rules and guidelines where applicable.
• Serves as the primary contact for global data acquisition and tabulation OR analysis and data submission standards for core global and/or assigned Therapeutic Area ensuring timely and quality deliverables
• 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.
• Accountable for driving the efficient, high quality and timely implementation of new standards and/or updates to standards; In collaboration with representatives across Data Operations disciplines and key stakeholder and partner functions within GDO and across Global Drug Development, lead the accurate translation of scientific and analytical requirements into efficient, compliant standards.
• Support and ensure the appropriate and efficient governance and approval of global and project/study specific clinical data standards liaising with governance boards as needed.
• 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. Act as an expert consultant providing Clinical Data Standards input to all relevant areas including; 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.
• Lead and contribute to Clinical Data Standards planning, definition, development, validation and support within assigned standards discipline (domain) including the development and maintenance of associated metadata, documents, business rules and guidelines where applicable.
• Serves as the primary contact for global data acquisition and tabulation OR analysis and data submission standards for core global and/or assigned Therapeutic Area ensuring timely and quality deliverables
• 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.
• Accountable for driving the efficient, high quality and timely implementation of new standards and/or updates to standards; In collaboration with representatives across Data Operations disciplines and key stakeholder and partner functions within GDO and across Global Drug Development, lead the accurate translation of scientific and analytical requirements into efficient, compliant standards.
• Support and ensure the appropriate and efficient governance and approval of global and project/study specific clinical data standards liaising with governance boards as needed.
• 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. Act as an expert consultant providing Clinical Data Standards input to all relevant areas including; 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.
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
• BS/BA/MS in computer science, management information systems, health sciences, statistics, or related field. At least 8 years industry experience in one of the following fields.
• EDC development and implementation preferably using Medidata-Rave, Data Management Clinical, Statistical Programming using SAS and CDISC data standards
• Advanced 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.
• Other programming languages such as Visual Basic, SQL-PL/SQL and C# or Java preferable. Data Analysis and reporting. SAS and other statistical programming languages/software (e.g. R); Understanding of statistical programming/statistical concepts in clinical trials
• Other programming languages such as Visual Basic, SQL-PL/SQL, XML, Python preferable. Advanced understanding and knowledge of regulatory requirements and industry standards relevant to data management and statistical programming (including GCP, ICH)
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we
achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
• EDC development and implementation preferably using Medidata-Rave, Data Management Clinical, Statistical Programming using SAS and CDISC data standards
• Advanced 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.
• Other programming languages such as Visual Basic, SQL-PL/SQL and C# or Java preferable. Data Analysis and reporting. SAS and other statistical programming languages/software (e.g. R); Understanding of statistical programming/statistical concepts in clinical trials
• Other programming languages such as Visual Basic, SQL-PL/SQL, XML, Python preferable. Advanced understanding and knowledge of regulatory requirements and industry standards relevant to data management and statistical programming (including GCP, ICH)
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we
achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Development
GCO GDD
India
Navi Mumbai
Nov Hltcr Shared Services Ind
Research & Development
Full Time
Regular
No
