Novartis
Clinical Scientific Expert I
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Job Description
- Req#: 382209BR
“150! Clinical scientific experts, globally, are part of Global Drug Development (GDD) team, working to ensure clinical trial data and regulatory reports are of highest quality throughout the life cycle of each program, across all disease areas. Be part of a dedicated, passionate team that is diligently providing clinical and scientific inputs at study and program level, thereby supporting Novartis in reimagining medicine for patients worldwide.”
Your responsibilities include, but are not limited to:
• Responsibility for ensuring high quality clinical trial data review/insights and analysis as directed by the Integrated Clinical Trial Team (iCTT)
• Perform high quality clinical data review and identify clinical data insights through patient level review and trends analysis, supporting Interim Analysis, Database and Post Lock activities and facilitate resolution of clinical data issues. Collaborate with relevant line functions to enhance the quality of clinical data review/insights with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review.
• Contributes to the development the Data Review/Quality Plan (DRP/DQP) and data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study.
• In conjunction with the relevant line functions, may contribute to Case Report Form (CRF) development, and support the implementation of data capture tools.
• Contribute to and facilitate data review process improvements e.g. identification of delinquent/redundant reports and/or implementation of innovative data analysis processes and tools.
• May contribute (in collaboration with relevant line functions) to the development of study-level documents, including clinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updates and submission dossiers. In collaboration with relevant line functions, review/write clinical trial documents for study CSR activities, and publications.
• May support pharmacovigilance activities (e.g., reviewing/contributing to aggregate reports/patient narratives, attendance of Safety Monitoring Meetings (SMT)), if required.
• Produce training materials and provide training to iCTT.About the company
At Novartis, we are reimagining medicine to improve and extend people’s lives. We are working hard to produce breakthroughs and address unmet needs for patients with devastating diseases, including genetic disorders and certain deadly cancers. Learn mo...
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