摘要
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 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 assigned.
About the Role
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
locations: #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. 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
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 here: https://talentnetwork.novartis.com/network
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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
