IRT Vendor Start Up Manager
Location
Poland
Posted
1 day ago
Salary
zł250K - zł280K / year
Seniority
Senior
Job Description
IRT Vendor Start Up Manager
Parexel
• Reviewing of the vendor and category related specific sections of the protocol, ensure 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 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. • Supports program overview by providing study demands to VCE. • Ensures all submission documents are provided by vendor, as required, to countries participating in a study. • Works closely with trial and monitoring teams to understand site requirements for study participation. • Ensures changes to country and site plans are consistently shared with vendors and VCE for start-up, resupply and close out. • Supports amendment of vendor contracts with Procurement team. • Optimizing a frontloaded and timely study start-up process in support of a timely site readiness. • Vendor service excellence at study level, ensures 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. • Escalates issue if required to the Vendor Category Expert VCE. • Drive root cause analysis of supplier performance issues and look for trending. • Supports the implementation of standards, templates, tools, and processes for vendors for defined categories in collaboration with the VCE. • Using Unified Vendor Portal (UVP) to manage vendor service delivery. • Supports practice leaders in improvement projects and learning loops. • Collaborate across the sponsor’s departments to provide data for vendor qualification efforts. • Review and approve invoices against activity. • In partnership with the vendor, develop site and monitor training material, and attend/support training if needed.
Job Requirements
- Advanced degree in science or business with equivalent experience
- 3+ years working experience and excellent knowledge of the clinical operation processes and vendor management
- Experience designing IRT Systems
- Experience in UAT
- Excellent knowledge of GxP and ICH regulations
- Expert knowledge of clinical trial design and mapping to supplier requirements
- Experience working with and Managing Patient Recruitment and Retention vendors/services
- 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
- Knowledge of key deliverables that impact green light milestones and vendor readiness
- Experience in outsourcing, contracting, sourcing of clinical services with IRT Vendors.
- Specific category expertise – ideally experience of global equipment supply and/or radiation, but this is not a necessity
Benefits
- Premium salary
- Attractive benefits
- Medical care plan: Health, Dental & Vision
- Life Assurance
- Excellent work environment
- Culture of teamwork and collaboration
- People who motivate and face challenges together
- Innovative technology
- Excellent training
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