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