As a representative of Research & Development Quality (RDQ), the Associate Director of Data Operations & Analytics will support key business processes related to Database Development, Data Management, Statistical Programming, and Analytics. This role involves providing expertise and guidance to ensure that clinical data flow, management, and analysis meet Novartis standards, Health Authority regulations, and Good Clinical Practice (GCP) guidelines. The Associate Director will collaborate with various teams to identify quality risks and recommend control and mitigation strategies.
Key Responsibilities:
Provide quality oversight to ensure compliance with standards and regulations throughout the data flow and analysis processes, including electronic data capture systems and clinical study report development.
Assist business functions during audits and inspections, including preparation and response to requests, as well as Corrective and Preventive Actions (CAPA) development.
Partner with various business units to implement digital capabilities and data science technologies into the drug development and clinical trial processes.
Serve as an ambassador for Novartis values and behaviors.
Collaborate with functions such as Global Data Operations, Pharmacovigilance, Clinical Development, and IT to develop effective business strategies for Database Development and Analytics.
Ensure that quality documents (guidelines, SOPs, etc.) are fit for purpose and compliant with Novartis standards and regulatory requirements.
Support the evaluation of new processes and technologies, ensuring they undergo thorough risk assessments.
Provide consultancy for Integration and Due Diligence activities related to Business Development and Licensing.
Proactively identify quality and compliance risks and assist the business in establishing mitigation mechanisms, applying Clinical Trial Quality Risk Management concepts as appropriate.
Guide investigations and root cause analyses for quality incidents in alignment with change management processes.
Contribute to cross-functional projects aimed at improving Novartis standards and simplifying workflows.
Promote a collaborative culture through educational initiatives, training sessions, and knowledge sharing.
Over 10 years of relevant experience in the pharmaceutical industry or public health sector, focusing on Quality, IT, Data & Digital, or Clinical Development.
Strong knowledge of GCP, Pharmacovigilance, and other Health Authority regulations, with a solid understanding of CSV and Part 11 requirements.
Excellent interpersonal skills demonstrating Novartis values, with the ability to bridge quality, scientific, and business perspectives.
Flexibility and creativity in problem-solving to meet business objectives.
High learning agility and a keen interest in continuous improvement.
Strong communication skills across various audiences and organizational levels.
Ability to build effective relationships with internal and external partners and manage change while maintaining high ethical standards.
Our mission is to reimagine medicine to enhance and extend lives. We strive to become the most valued and trusted medicines company in the world, driven by our associates. Be part of our mission to improve patient lives globally.
Novartis is dedicated to creating an inclusive work environment that reflects the diversity of the patients and communities we serve.
We are committed to providing reasonable accommodations for individuals with disabilities. If you need assistance during the recruitment process or to perform essential job functions, please contact us at diversityandincl.india@novartis.com, including the job requisition number in your message.
If this role isn’t a perfect fit but you’d like to stay informed about future opportunities, join the Novartis Network here.
To learn more about our comprehensive benefits and rewards, please refer to the Novartis Life Handbook here.
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