BMD post-graduate is part of Laboratory Excellence and Operation team in Biomarker Development which provides compliance, operational, sample planning/coordination, vendor management and data monitoring capabilities to other internal Novartis functions.
Specific responsibilities of BMD Fellows will include: • Gaining familiarity with a wide range of innovative biomarker platforms and laboratory technologies used in clinical research. • Develop and provide operational review of study protocols, site operations manuals, biomarker sample logistics including study setup, sample tracking/reconciliation, and data upload. • Perform logistical and operational activities for cellular and other biomarkers, coordinating with sites, managing and tracking material supply and sample at sites, central lab, and CROs • Monitor and provide oversight of BM modalities and laboratory assays (e.g. flow cytometry, Immunoassays) and coordination activities as assigned • Work with internal functions, clinical teams, CROs clinical trial leaders to trouble shoot and resolve issues related to biomarker monitoring • Travel and provide onsite training to clinical sites and external service providers • Contribute to clinical trial teams, working with Biomarker Experts and Clinical Trial Leaders to develop biomarker plans for implementation in clinical studies. • Leading and contributing to process improvement projects, technology evaluations and other initiatives across NIBR sites.
• Recent postgraduate degree in a Scientific field: PhD or PharmD • Fluent oral and written English • Previous laboratory experience in Biomarker analysis technique (LC-MS, Immunoassays, Flow cytometry) • Previous experience in Clinical Trials is preferred but not required • Good organizational and interpersonal skills
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