Clinical Vendor Manager

Clinical Vendor Manager

12 months

Remote / Reading

Up to £500 per day via Umbrella

University degree or comparable education with several years of experience in the area of clinical development. In-depth knowledge of clinical development and drug development process, ICH-GCP, applicable legal, compliance and regulatory requirements as well as experience with contracts and vendors, and Project Management experience are also required.

Major Tasks:

  • First point of contact for different stakeholders (such as Study Team functions, SSM, Category Leads, Contract management and similar) regarding supplier management topics.
  • Link between the Procurement organization and the CO operational functions to coordinate supplier qualification and maintain supplier performance including reliable documentation
  • Holistic oversight of external suppliers used/contracted in CO (incl.insourcedARO,CRO) forinterventional clinical studies
    • Manages supplier performance in a holistic way across trials.
    • Responsible for continuous quality evaluation of Service Provider in cooperation with Study Team, PRO and Audit
    • Leads and manages reviews of quality evaluation of a pool of preferred suppliers for CO outsourced services
    • Maintains list of potential suppliers and qualified services and advises Study Teams and other stakeholders on use and performance
    • Drives performance assessment/feedback in databases (e.g. via supplier satisfaction feedback from Study Teams, Lessons Learned) and stores documents in databases including documentation for audits and inspections
    • Provides guidance on supplier quality based on feedback from qualifications process and potential change of service after performance assessment
    • Acts as point of contact for escalation of quality issues with suppliers in trials.
  • Drives external partner qualification in cooperation with PRO and Audit
    • Supplier KOM participation depending on trial needs and vendor specific
    • Identifies and informs stakeholders on decision/request to qualify supplier service
    • Develops qualification plan including timelines based on GCT agreed qualification scope
    • Sets up qualification team consisting of core team and subject matter experts
    • Re-confirms qualification scope with GCT via CPM
    • Selects qualification questionnaires and assigns tasks
    • Collects input from the pre-agreed RPs
    • Files qualification documentation including completed questionnaires on Supplier Qualification SP
    • Leads Qualification Team and drives agreement on supplier service qualification
    • Ensures qualification follow up items are completed and documented
    • Maintains tools for supplier qualification
  • Provides feedback loop for QSDs dealing with management of suppliers.
  • Supports process improvement activities within related to Supplier Management
  • Supports Study Teams with regard to scope definition
  • Location

    Reading, Berkshire

  • Sector:

    Pharmaceuticals

  • Job type:

    Contract

  • Salary:

    £400 - £500 per day

  • Contact:

    Experis UK

  • Job ref:

    BBBH131712_1610127429

  • Published:

    18 days ago

  • Duration:

    12 months

  • Expiry date:

    2021-02-05

  • Startdate:

    ASAP

  • Client:

    Experis Ltd