Preclinical Data Manager – (Senior Scientist)
Core
Managing the transfer and quality control of non-clinical study data from internal studies and external partners into Novartis data systems.
Role type
Senior Preclinical Data Manager
Builds
Novartis Study Data Warehouse
Domain
Pharmaceutical preclinical safety and regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Non-clinical data management, LIS systems (Pristima, Provantis), Business Intelligence tools (Spotfire, GraphPad, Qlik), Python, R, Genomics, Transcriptomics, Immunophenotyping, CDISC-SEND compliance
Preferred skills
Bioinformatics, Clinical Data Management, Regulatory Compliance, Toxicology
Responsibilities
Evaluate quality and accuracy of non-clinical data from internal and external sources, Align Preclinical Safety data requirements with protocols, Develop global processes for data management and quality control, Coordinate delivery of CDISC-SEND compliant study data, Drive strategy for including new data types in the data warehouse, Represent organization in industry-wide teams to influence regulatory policies
Seniority
Senior, hands-on IC
