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  • Salary: This role is remote based with an attractive bonus and pension package and training opportunities.
  • Job Type:Permanent

Posted about 2 months ago

  • Sector: Translational Science
  • Contact: Alex Butcher
  • Contact Email:
  • Contact Phone: 01403 216216
  • Start Date: 2021-09-27
  • Job Ref: V-47045
A Biomarker Bioanalysis Project Manager is required for our client who delivers expertise in the selection, use, interpretation, and bioanalysis of clinical biomarkers across multiple therapeutic areas by engagement and management of CRO suppliers for Pre-clinical and Clinical studies. You will provide bioanalytical scientific oversight, budgetary and project management of outsourced biomarker bioanalysis at contract research organisations on behalf of clients in clinical and pre-clinical development for human therapies.

Key Duties and Responsibilities:
• Provide oversight and management of method establishment, fit-for-purpose assay validation and oversight management and data review of the measurement and reporting of the sample analysis data
• Provide expertise and knowledge in the application and operation of quantitative bioanalytical techniques, including mass spectrometric chromatographic, ligand binding assays, flow cytometry.
• Interact effectively with various client functional/stakeholder groups involved in sample analysis and data processing. These will include the client CRO facing sample managers, CRO laboratory based bioanalytical scientists, client and contracted pharmacokinetic and pharmacology experts, data acquisition function and sample repository representatives.
• Provision of expert input in sourcing, selecting, and engaging appropriate CRO bioanalysis providers for clients
• Upload and verify bioanalytical data generated by CROs.
• Review of draft and final assay validation and bioanalytical sample analysis reports.

Key skillset / experience required:
• Degree in a biological science with a further higher degree as desirable
• Extensive knowledge of bioanalysis within regulatory environments (GLP and GCP).
• Comprehensive knowledge in design and operational execution of clinical and pre-clinical studies, toxicokinetic and pharmacokinetic analysis.
• Practical experience of managing and developing bioanalytical methods, assay validation and study data generation in clinical and pre-clinical studies.
• Knowledge of the application and operation of a range of bioanalytical techniques, mass spectrometric chromatographic, ligand binding assays, flow cytometry, and genomic technologies
• Experience in pharma and CRO industry supporting biomarker bioanalysis in a regulatory and clinical trial environment