Job Description Summary
Responsible for enabling seamless, real-time transfer of critical non-clinical study data from internal studies and external partners into Novartis data systems, while representing the organization in partner discussions and simplifying complex data transfer processes. Establishes and drives robust data quality control and source data verification frameworks to ensure accuracy, consistency, and completeness of datasets. Proactively identifies and resolves database gaps, streamlining processes to enhance efficiency and deliver high-quality, reliable data.
Job Description
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.
Skills Desired
Analytical Thinking, Bioinformatics, Clinical Data Management, Collaboration, Communication Skills, Critical Thinking, Data Analysis, Detail-Oriented, Ethics, Laboratory, Lifesciences, Organization, Problem Solving Skills, Regulatory Compliance, Reporting, Reports Writing, Technical Skills, Time Management Skills, Toxicology
