Summary
About the Role
Key Responsibilities:
RBQM Solution Development
- Leads RBQM platform configuration, develop specifications basis study documentation and inputs from study teams
- Leads the configuration of system to support data ingestion, transformation and provisioning required standard and study specific outputs ( e.g. KRIs, QTLs )
Technical Support & Maintenance
- Troubleshoot and resolve technical issues related to RBQM platform
- Support the impact analysis and delivery of post-production change requests.
- Identify quality issues & trends, perform root cause analysis, and recommend preventive actions.
- Represent Clinical Dataflow & Insights team in key study milestones /discussions (database go-lives, snapshots, dry runs, interim analysis, DB locks).
People, Project Engagement & Quality Management
- Serve as a Subject Matter Expert (SME) for Clinical Dataflow & Insights, providing expert guidance on best practices across studies and platforms.
- Translate complex business needs into required solutions/ reports/ Visualizations.
- Support Audits and Inspections.
Essential Requirements
- Minimum 9 years of experience in clinical review and report programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry
- Strong knowledge of any programming languages (SAS, Python, R etc.)
- Knowledge of Data Review and/or Business Intelligence tools (such as Central monitoring platform)
- Understanding of clinical data management systems and/or relational databases as applied to clinical trials
- Ability to translate technical concepts for non- technical users in the areas of central monitoring platform design and visualization development
- Strong verbal and written communication skills to work with our global partners and customers
- Understanding of Drug Development Process, ICH- GCP, CDISC standards and Health Authority guidelines and regulations
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
