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
