Vendor Start up Manager – eCOA

Emploi pas sur LinkedIn

🕒 il y a 2 jours

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

👔 Manager

🗣️🇺🇸🇬🇧 Anglais requis

D'où vient cette offre

Publiée sur la page carrières de ICON plc, pas via un site d'emploi

Repérée par Remote Rocketship il y a 2 jours

Toujours ouverte sur le site de ICON plc. Vérifiée il y a 3 heures.

Logo of ICON plc

ICON plc

10 000+ employés

Fondée en 1990

💼 Conseil

🏥 Santé

📦 Logistique

Consulting • Healthcare • Logistics

ICON plc est un fournisseur mondial de services cliniques, de conseil et commerciaux à travers divers secteurs des industries de la santé et pharmaceutique. Ils offrent une vaste gamme de solutions cliniques, incluant des essais cliniques décentralisés, des solutions de sécurité cardiaque, des laboratoires cliniques précoces et de l'imagerie médicale. ICON fournit également des solutions technologiques qui soutiennent le développement de médicaments depuis les premières phases jusqu'à la post-commercialisation. Leur expertise thérapeutique couvre les domaines cardiovasculaire, oncologie, médecine interne et plus encore, avec un fort accent sur les thérapies transformatrices telles que les thérapies cellulaires et géniques ainsi que les biosimilaires. ICON est reconnu comme un leader dans le domaine de l'Organisation de Recherche Clinique (CRO), apportant régulièrement un leadership éclairé et contribuant à des publications et événements de l'industrie. Leurs services sont conçus pour optimiser les essais cliniques, offrir de l'intelligence réglementaire et fournir des preuves du monde réel à travers une analyse de données robuste et des solutions centrées sur le patient.

Description

• Review vendor and category-specific protocol requirements and incorporate supplier expertise into final study specifications • Support development of Study Specification Worksheets (SSWs) for vendor selection and bidding • Partner with Procurement and vendors to evaluate proposals and quotations and support contract discussions • Assess and validate vendor budgets against project scope and quotations • Organise vendor kick-off meetings and facilitate vendor governance discussions throughout the study lifecycle • Coordinate collection and submission of vendor documentation for regulatory authority submissions • Lead User Acceptance Testing (UAT) for systems such as eCOA and IRT • Communicate protocol amendments and study design changes to vendors and update budgets, timelines, and service agreements • Drive study start-up activities supporting timely vendor database deployment and operational readiness • Oversee vendor performance against quality, timeline, and service standards • Identify vendor risks and develop mitigation and contingency plans • Monitor performance issues, implement corrective actions, and escalate concerns • Conduct root-cause analysis and identify supplier performance trends • Contribute to vendor management processes, templates, tools, and best practices

🎯 Exigences

• Advanced degree in a scientific, life sciences, or business-related discipline, or equivalent industry experience • Fluent in written and spoken English • 3+ years of experience within clinical operations, with strong expertise in vendor management and oversight • Solid understanding of GxP, ICH-GCP, and applicable regulatory requirements • In-depth knowledge of clinical trial design and translating study requirements into vendor deliverables • Strong understanding of supplier-provided clinical services and associated operational specifications • Demonstrated experience managing vendor relationships and collaborating with external service providers • Proven ability to build effective partnerships with internal and external stakeholders • Experience leading or supporting User Acceptance Testing (UAT), particularly for eCOA and IRT platforms • Understanding of study start-up milestones, vendor readiness activities, and critical path deliverables • Experience supporting outsourcing, vendor selection, contracting, and procurement processes, including RFPs and RFQs • Expertise in one or more clinical vendor categories, such as Central Laboratories, eCOA/ePRO, IRT, Imaging, Cardiac and Respiratory Diagnostics, or Patient Recruitment and Retention (PR&R) • Legal right to work in the country where the role is based

🏖️ Avantages

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways

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