The CDS I 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, identifying clinical data insights to ensure data is scientifically plausible and to identify trends, signals, and risks associated with trial endpoints and patient safety.
About the Role:
Major Accountabilities:
- Implementing issue resolution plans.
- Assisting with program level activities (e.g., tracking of program).
- Managing interactions with relevant line functions including data management, drug supply management, clinical development, and/or Novartis Country Pharma Organizations.
- Reporting of technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt.
- Distribution of marketing samples (where applicable).
Key Performance Indicators:
- Timely, efficient, and quality execution of assigned trials and trial-related activities within budget, and in compliance with quality standards.
- Proactive operational planning with effective contingency and risk mitigation plans.
- Performing clinical data review and insights consistently and accurately, meeting Novartis quality standards, timelines, and inspection readiness.
- High-quality contributions to study documents (e.g., protocol, ICF, clinical sections of CTA).
- Clearly demonstrating Novartis Values and Behaviors (i.e., Innovation, Quality, Collaboration, Performance, Courage, and Integrity).
Minimum Requirements:
Work Experience:
- Cross-Cultural Experience.
- Operations Management and Execution.
- Collaborating across boundaries.
- Project Management.
Skills:
- Clinical Research.
- Clinical Trial Protocol.
- Clinical Trials.
- Data Integrity.
- Learning Design.
- Life Sciences.
- Risk Monitoring.
- Trends Analysis.
Languages:
- English.
