IRT Vendor Start-up Manager - UK (Home-based) - FSP

Parexel FSP has an exciting opportunity for an IRT focused Vendor Start-up Manager to join our single sponsor dedicated team, based in either the UK or Ireland.

Job Summary:

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.

Key Accountabilities :

Operational Management/Deliverables

• 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.

• 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.

• IRT 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 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.

Skills:

• Very strong IRT vendor management skills.

• Demonstrated strategic skills; organisational knowledge; advanced planning and project management skills, as well as an advanced understanding of business processes.

• Partnering skills with internal and external stakeholders.

• Strong problem solving, negotiation, deadline driven and conflict resolution abilities.

• Strong influencing skills and timeline driven.

• Proficient in written and spoken English.

Knowledge & Experience

• 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.

Education:

• Bachelor's degree in science or business required, with equivalent experience.

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