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Clinical Biomarker and Diagnostics Operations Lead - Oncology

Company: Spectraforce Technologies Inc
Location: Berkeley
Posted on: January 8, 2022

Job Description:

Clinical Biomarker and Diagnostics Operations Lead - Oncology 08-18-2021 Thousand Oaks, CA 292836 Job Description Clinical Biomarkers and Diagnostic Operations Lead -Oncology
Duration: 3 Years
Location: Thousand Oaks or San Francisco
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*****Open to fully remote, must work PST time zone.
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Job Requirements:

  • The Clinical Biomarker and Diagnostics (CBD) Operations Lead - Oncology plans and coordinates all project management and operational activities required for the collection, delivery and analysis of biomarker and diagnostics bio samples within one or more clinical projects or clinical studies.
  • He/she ensures continuity across projects, coordinates assay activities.
  • And acts as the primary point of contact for CBD operations for projects requiring biomarker and diagnostic activities. -
    Essential Duties and Job Functions:
    • Drives the implementation of the clinical biomarker and diagnostic plans for therapeutic programs in early and late stage clinical development across therapeutic areas.
    • Accountable for the development of a project and/or clinical study biomarker and diagnostics bio samples strategy.
    • Accountable to ensure the logistical feasibility of a project and/or clinical study biomarker and diagnostics bio samples strategy, considering appropriate logistical options and costs.
    • Accountable for planning and implementing the biomarker and diagnostics bio samples collection within a project(s) or clinical study including definition of the appropriate material, instructions etc.
    • Accountable for project management and appropriate forecasting and planning of related biomarker analysis and samples management costs within a project(s) or clinical studies.
    • Serves as first point of contact for biomarker and diagnostics bio samples operational questions within a project(s) and coordinates with other functions within and outside of the company (e.g., Bio-Sample Management, Clinical Operations, Biomarker and Diagnostic Leads).
    • Develops a sample reconciliation plan for each sample type including data management for relevant data collection and reporting within studies while also ensuring consistency of reconciliation activities within project(s).
    • Reviews study protocols and sample collection ICFs prior to finalization and provides input to ensure the protocol and ICFs enable sample testing according to the Biomarker and Diagnostics plans.
    • Project manages the implementation of clinical trial assays at reference labs and centralized testing vendors, ensures delivery of assay/ data results and is a key contact for the assay lab.
    • Project manages contracts, budgets and time-lines for biomarker activities within studies to ensure timely completion of biomarker and diagnostic activities.Education/Qualifications
      • Life Sciences degree (higher qualification e.g. MSc or equivalent preferred).
      • Further qualification, e.g. project management certification is desirable.4+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environmentExperience, Skills, Knowledge
        • Extensive clinical development experience of working in teams running clinical studies Clinical or biological laboratory experience with involvement in the processing and/or analysis of biological samples
        • Project management skills and knowledge of project management tools Critical reasoning skills including the identification and resolution of complex problems
        • Detail oriented with the ability to work independently and manage multiple competing priorities Excellent planning, organizational and time management skills Effective communication skills Hi, my name is Kaur Navdeep
          Let me know if you have questions Don't see your next job? Submit your resume anyways and we'll let you know when we find the perfect job for you

Keywords: Spectraforce Technologies Inc, Berkeley , Clinical Biomarker and Diagnostics Operations Lead - Oncology, Healthcare , Berkeley, California

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