As a global leader in the pharmaceutical industry, Novartis is committed to reimagining medicine to improve and extend people's lives. We are seeking an Associate Director, Data Operations & Analytics RDQ to join our team and support critical business processes within Research & Development (R&D). In this role, you will provide expertise and guidance to ensure the clinical data flow, management, and analysis processes meet Novartis standards, Health Authorities regulations, and GCP guidelines.
As a key member of the Research & Development Quality (RDQ) team, you will support data management, statistical programming, and analytics processes. You will work closely with internal teams and stakeholders to identify and mitigate quality risks, ensuring the effective integration of new technologies and digital capabilities into the clinical trial process.
Quality Oversight: Provide quality advice and oversight to ensure adherence to required standards and regulations throughout the data flow and data analysis lifecycle (e.g., study development, data capture, study conduct, statistical analysis, and clinical report development).
Audit and Inspection Support: Assist relevant business functions during audit/inspection preparations, respond to requests, and support Corrective and Preventive Action (CAPA) creation.
Cross-Functional Collaboration: Partner with various business units (e.g., Global Data Operations, Clinical, IT, and Pharmacovigilance) to integrate digital technologies, data science, and innovative solutions into drug development and clinical trial processes.
Process and Documentation Compliance: Ensure that quality documents (guidelines, SOPs, etc.) are fit for purpose, meet Novartis standards, and comply with Health Authorities regulations and GCP guidelines.
Risk Management: Proactively identify regulatory, quality, and compliance risks within assigned projects and collaborate with the business to establish effective mitigation strategies. Apply Clinical Trial Quality Risk Management principles.
Investigation and Root Cause Analysis: Provide expertise and guidance in the investigation of quality incidents and change management processes.
Continuous Improvement: Contribute to cross-functional projects to improve Novartis standards, processes, and systems, ensuring process adherence and simplifying operations.
Training and Knowledge Sharing: Foster a culture of collaboration by providing training, lessons learned, and sharing successes with internal and external partners/stakeholders.
Consultancy and Support: Provide support in Integration and Due Diligence activities linked to Business Development and Licensing (BD&L) for relevant business functions and processes.
Other Duties: Support additional tasks within the GDD Quality Data & Digital Processes scope, including deputizing for peers and managers as needed.
Experience: Over 10 years of relevant experience in the pharmaceutical industry or public health sector, specifically in Quality, IT, Data & Digital, and/or Clinical Development.
Regulatory Knowledge: Strong background in GCP, Pharmacovigilance, Health Authority regulations, and familiarity with CSV and Part 11 requirements, as well as privacy and information security regulations.
Collaboration Skills: Exemplary interpersonal skills, able to bridge gaps between quality, scientific, and business teams while demonstrating Novartis values of collaboration, quality, and integrity.
Problem-Solving: Flexible, innovative problem-solver, able to meet business needs while maintaining a focus on quality and compliance.
Learning Agility: High learning agility with a strong interest in continuous improvement and the ability to manage complex projects.
Effective Communication: Ability to communicate effectively with diverse audiences and organizational levels.
Relationship Building: Proven ability to build strong relationships with internal and external partners.
Change Management: Experience in driving change and fostering a culture of high ethical standards and compliance.
At Novartis, our mission is to reimagine medicine to improve and extend the lives of patients worldwide. We believe that our associates drive us forward to achieve this goal. As an employee, you will be part of a company that fosters innovation, collaboration, and continuous personal and professional growth.
Learn more about our mission and culture: Novartis Strategy: People and Culture
Explore our benefits and rewards: Novartis Life Handbook
Join our Novartis Network: Talent Community
Novartis is committed to working with individuals with disabilities and providing reasonable accommodations. If you require assistance during the recruitment process, please contact diversityandincl.india@novartis.com.
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