Job Description

Job Description Summary 100,000 patients participate in our clinical trials at any given time. Global Clinical Operations (GCO) connects science and medicine, impacting lives daily. Envision your impact as the Therapeutic Data Strategy Director! The TDSD bridges science and operations by defining clinical data strategy operationalization across GCO's data flow. Responsibilities include ensuring data regulatory compliance, maintaining End-to-End standards, discussing and finalizing instruments and devices before database build, and assessing operational impacts of changes. In collaboration with GPT, the TDSD aligns on fit-for-purpose data packages to support data strategy throughout drug development within an assigned therapeutic area at Novartis. This role manages the end-to-end data product, applying clinical data standards and defining strategies for data acquisition, review, analysis, and reporting to support clinical submissions. If creating a program-level data strategy that emphasizes agility, cycle time reduction, and cost efficiency excites you, consider applying. Your Key Responsibilities: Operational Execution of the Program Strategy: Lead and maintain data strategies for clinical data processes, assess costs and impacts, drive resource planning, and ensure resource skillsets for E2E specifications. End-to-End Ownership of Clinical Data Flow: Implement lean data strategies, collaborate on quality-by-design reviews, and ensure data quality supports decision-making. Standards Oversight & Lifecycle Management: Ensure compliance with data standards, influence new standards design, and govern data transfer specifications. Operational Project Management: Develop and implement global data operational strategies, ensure adherence to timelines, and promote strategy adoption across teams. Minimum Qualifications: Bachelor's degree in life sciences, preferably with statistics. At least 15 years' experience in R&D within a regulated pharmaceutical or healthcare environment. Strong understanding of clinical data processing and trial operations. Extensive knowledge of ICH-GCP processes and regulations; clinical operations experience preferred. The company supports reasonable accommodations for qualified individuals with medical restrictions without eliminating essential functions. Why Novartis: Join us to help people with disease, working with passionate colleagues to achieve breakthroughs that change lives. Learn more: Benefits & Rewards: Discover our benefits at Diversity & Inclusion: We are committed to equal opportunity employment, fostering a diverse and inclusive workplace that drives innovation and empowers our employees. Compensation: The salary range is $192,000 - $288,000, with potential bonuses and benefits. Final compensation depends on various factors including location, experience, and skills. Join Our Network: Stay connected for future opportunities: EEO Statement & Accommodations: We provide accommodations for applicants with disabilities. Contact tas.nacomms@novartis.com or call +1 (877)395-2339 for assistance. #J-18808-Ljbffr Novartis Group Companies

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