Preclinical Data Manager – (Senior Scientist)

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.