Direct Hire/Full Time

We are seeking a  Clinical Sample Operations Manager to plan and coordinate all operational activities required for the collection, delivery and testing of clinical biomarker or diagnostic samples within a clinical study.

Primary Responsibilities and Accountabilities:

  • Responsible for the development and implementation of the clinical biomarker operations strategy, including CRO management, lab manual generation, sample collection and shipping logistics, and budget, etc.
  • Aligns processes surrounding vendor selection and management
  • Acts as the primary point of escalation for issue resolution
  • Provides input on Protocol and ICF development
  • Identifies novel and innovative clinical sample collection and processing techniques and ensures logistical feasibility
  • Manage timelines for sample testing and data transfer with both internal teams and external vendors
  • Single point of contact for status of clinical trial samples and biomarker data, provide sample and assay status updates
  • Manage sample transfer/discrepancy resolution with Central Lab and other sample analysis/storage CROs
  • Support/participate in preclinical biomarker identification effort as needed

Requirements:

  • Bachelor’s Degree in scientific or related field and a minimum of 3-5 years’ related experience;
  • Experience with NGS preferred;
  • CRO/vendor selection and management experience preferred
  • Clinical sample handling and management;
  • Drafting and reviewing of lab related clinical trial documents (protocol, ICF, lab manual, etc.), preferred
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To apply for this job email your details to info@clinlabstaffing.com