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About the Role
Key Accountabilities:
- Evaluate quality and accuracy of non-clinical data received from internal studies and external partners and liaise the same to resolve discrepancies with corrective actions, where needed.
- Align Preclinical Safety data requirements with protocols, reports, etc. in close collaboration with Study Directors/Leads/ Subject-Matter Experts to ensure complete and meaningful transfer of data.
- Involve in developing global processes/guidelines for data management and quality control.
- Coordinate with relevant teams to ensure timely delivery of CDISC-SEND compliant study data from external test sites and contributing scientists to the Novartis Study Data Warehouse.
- Partner with different Preclinical Safety line functions to define the purpose, need and precise details to be included for data collection and documentation of data as per the internal/ external quality compliance requirements.
- Drive strategy of including new data types or sources, e.g., genomics, transcriptomics, immunophenotyping in the Novartis Study Data Warehouse, according to emerging needs from Preclinical Safety and Regulatory requirements.
- Represent Novartis on industry wide teams to impact/ influence regulatory policies
- Coordinate with Preclinical Safety management and operations to define goals, objectives and Key Performance Indicators to include in contracts/expectation documents with ex-ternal partners
Minimum Requirements:
- Experience working with large data sets especially from the pharmaceutical industry for example (clinical pathology, in-life findings, toxicokinetic, pathology, genomics, etc.)
- Experience using LIS, particularly Pristima or Provantis.
- Competence with Business Intelligence data visualization tools (ex: Spotfire, GraphPad, Qlik) Scripting experience (Python, R) is a plus
- Graduate/ Postgraduate in Life Sciences/ Computer Science/ Computer applications with 3-5 years relevant experience in preclinical data management.
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.
Read our handbook (PDF 30 MB)
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.
