Covance

  • Clinical Team Lead

    Job Location(s) TW
    Job Number
    2018-21418
    Job Category
    Clinical Operations
    Position Type
    Full-Time
  • Job Overview

    We are hiring Clinical Team Lead in Taiwan and based at our pharmaceutical client sites for project management.

     

    • Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).
    • Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
    • Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, sponsor policies and procedures, quality standards and adverse event reporting requirements internally and externally.

    o Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.

    o Performs Quality control visits as required

    • Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration
    • Responsible for creating and executing a local risk management plan for assigned studies
    • Ensures compliance with CTMS, eTMF and other key systems in assigned studies
    • Escalates as needed different challenges and issues to TA Head/CRD/CQM and or CTT (as appropriate)
    • Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies
    • Collaborates internally with HQ functions and locally with PV, Regulatory and GMA to align on key decisions in his/her studies. GHH to be consulted as needed.
    • Shares protocol-specific information and best practices across countries\clusters

    Education/Qualifications

    B.A./B.S. preferred with strong emphasis in science and/or biology

    Experience

    10 years of experience in clinical research including 3 years as CRA, 2 years as project management

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