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Clinical Trial Manager

Details

  • Location San Diego, California
  • Job Type Direct
  • Pay $100,000.00
  • Category A&F
  • Date Posted Oct 12, 2017

Overview

About the Company

Our client, a clinical-stage biotechnology company developing unique oncologic drugs treatments, is currently seeking a Clinical Trial Manager to join their rapidly growing team. The Clinical Trial Manager will manage various aspects of clinical trials from study start-up through database lock in coordination with clinical operations leadership and later commercialization.

Responsibilities

  • Managing operational aspects of clinical trials from study start-up through database lock as assigned, with adherence to stated goals, timelines, budgets, and applicable regulatory requirements.
  • Managing study-related vendors including CROs and contract labs.
  • Reviewing monitoring reports, protocol deviations and data listings to ensure reliable quality data is and has been delivered
  • Performing site visits (qualifications, initiations, routine monitoring visits, closeouts) and ensuring visit-related documents are generated

Qualifications

  • Bachelor’s degree or equivalent in the life sciences or related field
  • 7 + years of experience with site monitoring and study/ CRO vendor management with previous experience with oncology, combination drug-device studies, and/or global clinical trial experience
  • Strong working knowledge of drug development process, GCP, ICH guidelines and FDA regulations.
  • ACRP CCRA certification a plus
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