Job Description Summary Bringing life-changing medicines to millions of people, Novartis sits at the intersection of cutting-edge medical science and innovative digital technology. As a global company, the resources and opportunities for growth and development are plentiful including global and local cross functional careers, a diverse learning suite of thousands of programs & an in-house marketplace for rotations & project work. With a strong medicines pipeline, our current transformation will not just deliver growth for our business but continue to allow us to bring innovative medicines to patients quickly.
The Clinical Scientific Expert 1 (CSE) provides clinical and scientific support through all phases of a clinical study under the guidance of the (A)CD(M)D in compliance with Novartis processes, ICH GCP and regulatory requirements. This role applies the principles of clinical data review excellence and identifies clinical data insights to ensure data is scientifically plausible and to identify trends, signals, and risks associated with trial endpoints and patient safety. The CSE I is a core member of the Clinical Trial Team (CTT) and will support program level activities as assigned.
Key responsibilities: Perform high quality clinical data review, and identify clinical data insights through patient level review and trend analysis, supporting interim analysis, Database Lock activities, emphasis on subject safety and eligibility, data integrity, trend identification, analysis, and remediation.Contribute to development of Data Quality Review Plan (DRP) and data review strategy.May contribute to Protocol development and CRF development.Contribute to and facilitate data review process enhancements and implementation of innovative data analysis processes and tools.May contribute to study level documents and submission dossiers.May support pharmacovigilance activities.Location: #LI-Hybrid Dublin office
Essential requirements: MSc in life sciences, ideally PhD/MD qualification.Scientific, strategic, and operational experience in planning, executing, reporting, and publishing clinical studies in industry or academia.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. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!
You'll receive: Competitive salary, annual bonus, pension scheme, share scheme, health insurance, 25 days annual leave, flexible working arrangements, subsidized dining facilities, employee recognition scheme, learning and development opportunities.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network.
Skills Desired: Clinical Research, Clinical Trial Protocol, Clinical Trials, Data Integrity, Learning Design, Lifesciences, Risk Monitoring, Trends Analysis.
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