Clinical Vendor Manager
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.
- 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