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Scientific. Clinical. Software Engineering

Senior Clinical Trial Manager

San Mateo Metro Area, CA

Job Type: Clinical Job Number: JN -052020-26786 Region: San Mateo Metro Area

Job Description

Our Bay Area client is recruiting for an experienced Senior Clinical Trial Manager.

Overview:

  • Manage the day-to-day operations of assigned clinical studies to ensure completion per established goals and objectives in compliance with applicable ICH/GCP guidelines and other regulatory requirements
  • Manage the study project plan including timeline, budget and resources
  • Provide oversight of vendors including CRO interactions and sponsor oversight of operational functional activities
  • Participate in the development, review and implementation of departmental SOPs and processes
  • Proactively identify potential study issues and recommends solutions

Qualifications:

  • BS/BA in life sciences or healthcare field preferred
  • 6-8 years of related clinical trial management experience
  • Strong experience in management of CROs and other vendors
  • Proven project management skills and study leadership ability
  • Strong working knowledge of FDA and EMA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials

**Local Candidates Only**

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