The professional will be responsible for contributing, with appropriate oversight, to all relevant aspects of global clinical trial(s) activities to deliver study outcomes within schedule, budget, quality/compliance, and performance standards.
May lead specific aspects of global clinical trial(s).
Core member of the Clinical Trial Team.The Clinical Scientific Expert I (CSE 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 and identifies clinical data insights to ensure data is scientifically plausible and to identify trends, signals, and risks associated with trial endpoints and patient safety.
The CSE I is a core member of the Clinical Trial Team (CTT) and may support program level activities as assigned.About the Role Work Model: HybridMajor accountabilities:Implementing issue resolution plans; assist 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).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 which meets the Novartis quality standards, timelines, and is inspection ready.High quality contributions to study documents (e.g.
protocol, ICF, clinical sections of CTA).Clearly demonstrates Novartis Values and Behaviors (i.e.
Innovation, Quality, Collaboration, Performance, Courage, and Integrity).Higher education in the area of Health.Experience as a Clinical Research required.Critical Negotiations.Advanced/Fluent English.Operations Management and Execution.Skills:Clinical Research.Clinical Trial Protocol.Clinical Trials.Data Integrity.Learning Design.Trends Analysis.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!You'll receive: Competitive salary, annual bonus, life insurance, home office policy (home office 2x a week), retirement and wellbeing plans, flexible working arrangements, birthday day-off, parental leave, subsidized dining facilities, health insurance, employee recognition platform, Gympass, employee resource groups, and virtual self-development tools.Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.#J-18808-Ljbffr