Clinical Scientific Expert I

Dublin - Ireland

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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 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 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.

Job Description

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.

Skills Desired

Budget Management Clinical Research Clinical Trial Protocols Clinical Trials Coaching Data Analysis Data Integrity Learning Design Life Science Risk Monitoring Trend Analysis

Job Description SummaryBringing 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 c...