Covance

  • CentralizedTripReprt Rev II

    Job Location(s) CN-Dalian
    Job Number
    2019-36859
    Job Category
    Clinical Operations Management
    Position Type
    Full-Time
  • Job Overview

     

    Site monitoring responsibility for clinical studies according to COVANCE standard operating procedures, ICH Guidelines and GCP.

    Site management responsibility for clinical studies according to COVANCE standard operating procedures, ICH Guidelines and GCP.

    Assures the implementation of project plans as assigned.

    Function as leader for projects of limited scope as assigned.

    Assume line management responsibilities as assigned.

    Act in the project role of a Local Project Coordinator or Lead CRA as assigned.

    Duties and Responsibilities: Individual Contributor

      

    Responsibilities:

    • Ensure accurate and timely trip report completion and trip report review and the quality of reports are of the highest standards, errors are minimized and that issues are escalated as appropriate
      • Follow project issue escalation process and Covance Corrective Action Issue Resolution (CAIR) process for clinical operations issues
      • Ensure site monitoring responsibility for clinical studies are conducted according to Covance
      Standard Operating Procedures, ICH Guidelines and GCP
      • Ensure follow up on action items and protocol deviations and to be a liaison between CRA, CTL and PM for timely resolution of issues
      • Responsible for the timely and appropriate communication to the clinical operations team
      • Liaise with CTL/PM to communicate any trends, outstanding issues, safety concerns or any other activity or lack thereof which may jeopardize the clinical trial delivery or patient safety.
      • Assures the implementation of project plans as assigned
      • Assist with training, mentoring, and development of new employees
      • Review progress of project and initiate appropriate actions to achieve target objectives
      • Contribute to improvements to enhance the efficiency and quality of work on assigned projects

    Education/Qualifications

    Graduate in any discipline preferable lifesciences.

    Experience

    7+ years of experience into Trip report reviewing.

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed

    Tell Us About Yourself

    Not ready to apply? Connect with us to join our talent network.