Senior Bioanalytical Study Manager - Client-dedicated - FSP

Thermo Fisher Scientific · Remote

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Clinical OperationsRemoteFull timeCompany career page

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Role summary

Senior Bioanalytical Study Manager role managing bioanalytical operations for pre-clinical studies and clinical trials at Thermo Fisher Scientific. Coordinate activities across internal and external stakeholders to ensure timely delivery of high-quality data, with particular focus on late-phase clinical studies.

What they're looking for

Bachelor's degree in scientific discipline plus 2+ years project/study management in bioanalytical laboratory
Experience in regulated bioanalytical, pharmaceutical, or clinical development environment
Strong understanding of clinical trial design and late-phase clinical development
Demonstrated practical experience with LC-MS bioanalysis
Experience with ligand-binding assays and large-molecule bioanalysis highly desirable
Strong regulatory awareness relating to bioanalytical activities in clinical development
Experience coordinating external laboratories/CROs and multiple stakeholders in complex programs

What you'll be doing

Support vendor contracting with third-party laboratory service providers for assay development and sample analysis
Manage bioanalytical activities across clinical studies including reagent supply and sample analysis coordination
Oversee bioanalytical work involving LC-MS and ligand-binding assay platforms for small and large molecules
Provide input into clinical trial documents and ensure quality, accuracy and timely delivery of bioanalytical data
Track clinical samples and resolve logistical issues impacting study timelines

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Date posted14 days ago

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