Job Description Summary
LOCATION: Dublin IrelandROLE TYPE: Hybrid Working, #LI-Hybrid
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 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 Clinical Development Director/Clinical Development Medical Director in compliance with Novartis processes,
International Council for Harmonization - Good Clinical Practice (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 to 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 ass
Job Description
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 Case Report Form (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
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:
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
Benefits and Rewards:
Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Skills Desired
Clinical Research, Clinical Trial Protocol, Clinical Trials, Data Integrity, Learning Design, Lifesciences, Risk Monitoring, Trends AnalysisNovartis Dublin, Dublin, IRL Office
203 Merrion Rd, Dublin, Ireland, D04 NN12
