IRT Vendor Start-up Manager – UK or Ireland
Location
United Kingdom
Posted
2 days ago
Salary
0
Seniority
Senior
Job Description
IRT Vendor Start-up Manager – UK or Ireland
Parexel
• The Vendor Start-up Manager (VSM) will provide technical expertise for the category throughout start-up to close out to the VCE (Vendor Category Expert) and indirectly to the Clinical Trial Team. • The VSM enables a flawless and accelerated vendor service delivery at the trial start-up phase and supports implementation of defined category strategies and service standardization and ensures compliance through the life of the studies assigned. • This role proactively assesses risk and concludes contingency plans to de-risk study start-up and beyond. • Reviewing of the IRT vendor and category related specific sections of the protocol, ensuring IRT vendor expertise is leveraged when refining specifications towards Final Protocol. • Contributing to development of Study Specification Worksheet (SSW) to facilitate bid process and selection of IRT Vendors. • Quote/Proposal review in collaboration with procurement (and vendor). • If required, support contract negotiations. • Vendor budget review of final quotes. • Accountable for Vendor cost control, budget review, invoice reconciliation and PO close-out. • Ensures all submission documents are provided by vendor, as required, to countries participating in a study. • Supports amendment of vendor contracts with Procurement team. • Optimizing a frontloaded and timely study start-up process in support of a timely site readiness. • IRT Vendor service excellence at study level, ensuring vendors meet quality and service level standards in their service delivery for the trial. • Acts as escalation point for vendor-related query management. • Pro-actively creates and maintains vendor related risk maps with contingency plan for documentation. • Follow-up with countries and Hubs for their vendor-related risks and issues. • Document issues identified with vendor oversight/performance in sponsor’s internal tool and implements and monitors corrective actions. • Drive root cause analysis of supplier performance issues and look for trending.
Job Requirements
- 3+ years working experience and excellent knowledge of the clinical operation processes and IRT vendor management
- Excellent knowledge of GxP and ICH regulations
- Expert knowledge of clinical trial design and mapping to supplier requirements
- Demonstrated leadership with supplier relationship management and/or expert knowledge of specific service areas
- Demonstrated partnering across divisions with internal and external stakeholders
- Demonstrated root cause analysis, problem solving, and solution generation skills
- Experience in IRT User Acceptance testing
- Knowledge of key deliverables that impact green light milestones and vendor readiness
- Experience in outsourcing, contracting, sourcing of clinical services with Vendor/CROs
- Bachelor's degree in science or business required, with equivalent experience.
Benefits
- Health insurance
- Flexible work arrangements
- Professional development opportunities
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