About the Role

　　Your responsibilities include, but are not limited to:

　　• Responsible for Clinical Data Standard/automation solution planning, definition, development, validation and support

　　• Serves as the primary contact for global / TA data standards and/or technologies ensuring timely and quality deliverables..

　　• Responsible for driving efficient, high quality and timely implementation of new standards and/or technologies. Ensure efficient governance and approval of global clinical data standards / technologies liaising with governance boards as needed.

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

　　• 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.

　　• Act as primary subject matter expert (SME) for assigned area providing support, consultation and training to end users and SME networks on implementation of standards and related tools on development programs.

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

　　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

　　• Provide highly advanced expert support and functional and technical leadership to ensure the scientific integrity/validity for clinical development, early development, and/or research projects.

　　• Develops and applies biostatistics and programming methods to ensure valid conclusions. Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries.

　　• May also provide statistical support to research or other R&D areas. To meet challenges in data review, big data, analytics and reporting of clinical trial data may also Independently provide timely and professional leadership of special projects that focus on innovative tools and systems.

　　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.

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　　Division

　　Development

　　Business Unit

　　GCO GDD

　　Location

　　India

　　Site

　　Hyderabad, AP

　　Company / Legal Entity

　　Nov Hltcr Shared Services Ind

　　Functional Area

　　Research & Development

　　Job Type

　　Full Time

　　Employment Type

　　Regular

　　Shift Work

　　No