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Form of work 100,000+ That’s how many patients participate in our clinical trials at any given time. GCO is Novartis’ powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine – imagine the impact you could have as [Role]! #GCO
The Principal Data Scientist is responsible and accountable for managing all Data Management activities using advanced data management tool and techniques with respect to cost, quality and timelines for all assigned projects/trials within a Clinical Program. The position is a key collaborator and strategic partner with stakeholders ensuring that data management activities for the clinical trials are executed efficiently with timely and high quality deliverables (in alignment with the Novartis Clinical Data Quality Statement). Provide active and effective communication to Clinical Trial Teams and other stakeholder groups
Your responsibilities include, but are not limited to:
• Lead data management activities as Trial Clinical Data Scientist for several studies or as a Program Clinical Data Scientist for a medium to large sized project in phase I to IV clinical studies in Novartis Global Development Organization.
• Co-ordinate activities of Data Scientist either internally or externally. Make data management decisions and propose strategies at study or project level. Ensures alignment with the TA level data strategy as defined by the TA Data Strategy Director
• Provides accelerated feedback to assure well written, stable protocols and amendments aligned with Program standards and requirements. Recognize and resolve protocol issues that may impact database design, data validation and/or analysis/reporting, minimizes the data footprint to focus on the trial endpoints and ensures utilization of available data standards.
• Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical data management aspects (timelines, scope, resource plan), e.g. as Clinical Data Acquisition & Management representative in study- or project-level team.
• Review eCRF, assess the need for additional study specific CRF, discuss data structures and review activities and ensure project-level standardization which allows pooling.
• Provide and implement data management solutions; ensure knowledge sharing. Act as data management expert in problem-solving aspects.
• Responsible for quality control and audit readiness of all assigned data management deliverables as well as accuracy and reliability of the Clinical Database. Act as subject matter expert (SME) or, as assigned, lead process improvement/non-clinical project initiatives
• Maintain up-to-date advanced knowledge of programming software used for creating reports or visualizations as well as industry requirements (e.g. CDISC /SDTM/ADaM). Establish successful working relationship on individual studies with external associates according to agreed contract and internal business guidance
