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Scientific. Clinical. Engineering

Clinical Biomarker Project Manager

San Jose Metro Area, CA

Employment Type: Full-Time Job Type: Clinical Job Number: JN -052022-30382 Region: San Jose Metro Area

Job Description

Our biopharmaceutical client is recruiting for a Clinical Biomarker Project Manager to join their growing team.

Summary:
  • Manage the biomarker operations and logistics to align with clinical trial schedule
  • Responsible for relevant clinical study documents and associated systems (including trial protocol, Informed consent forms, eCRFs, CSRs, etc.)
  • Oversee EC/IRB biomarker related inquiries, ensuring consistent responses across studies while maintaining study timelines
  • Manage biomarker vendor selection including contract execution and vendor oversight in compliance
  • Forecast and track study costs associated with sample and result management, bioanalytical assays, logistics and shipping
  • Oversee sample management including timely shipments to vendors and data is transferred to correct databases
Requirements:
  • Bachelor's Degree in life sciences and 10 years of project management and clinical operations experience
  • 2 plus years of direct clinical/biomarker operation experience from initiation through study completion
  • Oncology knowledge preferred
  • Effectively work in a cross-functional team environment and ability to interact with various levels within the organization as well as vendors
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