IRT Vendor Start Up Manager

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• 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.

🎯 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