As a Clinical Data Specialist I (CDS I) at Novartis, you will contribute to global clinical trial activities under the guidance of the Associate Clinical Director (ACD) or Clinical Data Manager (CDM), ensuring the timely and compliant execution of clinical studies. This role involves clinical data review, identifying data trends, signals, and risks related to patient safety and trial endpoints. You will be a core member of the Clinical Trial Team (CTT) and may lead or support program-level activities.
Key Responsibilities
- Clinical Trial Oversight: Assist with trial-related activities to ensure timely execution within schedule, budget, and quality standards.
- Clinical Data Review: Review and validate clinical data for scientific plausibility and identify trends or risks.
- Cross-functional Collaboration: Collaborate with data management, drug supply, clinical development, and country teams for trial-related functions.
- Issue Resolution: Implement resolution plans and support program-level tracking and planning.
- Compliance: Ensure compliance with Novartis processes, ICH GCP, and regulatory requirements.
- Reporting: Report adverse events and special case scenarios related to Novartis products within 24 hours of receipt.
Key Performance Indicators
- Efficient and high-quality execution of clinical trials.
- Proactive risk mitigation and operational planning.
- Accurate and consistent clinical data review aligned with Novartis quality standards.
- High-quality contributions to clinical trial documents (e.g., protocols, Informed Consent Forms, Clinical Trial Agreements).
- Demonstration of Novartis Values and Behaviors: Innovation, Quality, Collaboration, Performance, Courage, and Integrity.
Minimum Requirements
- Work Experience:
- Cross-cultural experience.
- Experience in operations management and clinical research.
- Strong collaboration skills and project management abilities.
- Skills:
- Clinical trial protocol knowledge.
- Data integrity and risk monitoring expertise.
- Ability to analyze trends and apply insights to trial data.
- Languages: Proficiency in English is required.
