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

　　Novartis is 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

　　Why Novartis?

　　766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.

　　We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

　　We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

　　Imagine what you could do here at Novartis!

　　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

　　Division

　　Development

　　Business Unit

　　GCO GDD

　　Location

　　India

　　Site

　　Mumbai

　　Company / Legal Entity

　　Nov Hltcr Shared Services Ind

　　Functional Area

　　Research & Development

　　Job Type

　　Full Time

　　Employment Type

　　Regular

　　Shift Work

　　No