Senior Clinical Research Specialist

🕒 il y a 11 jours

🌐 Royaume-Uni, Irlande – Distant

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💵 £50 400 - £75 600 / an

⏰ Temps Plein

🟠 Senior

🧪 Chercheur Clinique

🇬🇧 Parrain de Visa de Travailleur Qualifié UK

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🗣️🇺🇸🇬🇧 Anglais requis

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Medtronic

10 000+ employés

Fondée en 1949

🏥 Santé

🏭 Fabrication

⚕️ Assurance santé

Healthcare • Manufacturing • Healthcare Insurance

Medtronic est un leader mondial des technologies de santé, qui s’emploie à répondre aux pathologies les plus complexes et les plus exigeantes. Avec plus de 95 000 collaborateurs dans plus de 150 pays, l’entreprise met l’accent sur l’accélération de l’accès aux technologies de santé et sur la promotion de l’inclusion, de la diversité et de l’équité dans le domaine de la santé. Medtronic collabore étroitement avec les professionnels de santé pour innover et optimiser les traitements et les thérapies, inspirant ainsi l’espoir et de nouvelles possibilités pour les patients du monde entier. L’engagement de l’entreprise en faveur de la santé se traduit également par des solutions à fort impact et par l’adoption de pratiques durables.

Description

• Oversee investigator-sponsored research from initial review, contracting, and active study management through close-out and publication • Manage study device shipments, returns, and associated logistics • Handle ISR costing, budgeting, invoicing, payment processing, and asset depreciation tracking • Coordinate contract negotiations and align internal cross-functional stakeholders • Maintain Trial Master Files (TMF) and ensure compliance with GCP, ISO 14155, regulatory requirements, and internal SOPs • Serve as the European representative on the global ISR Council of Expertise • Help develop and update study policies and procedures • Assist Medtronic-sponsored studies with payments, budget management, and Global Compliance Committee (GCC) approval workflows • Act as Subject Matter Expert for purchasing systems, clinical trial management platforms, HCP interactions, and operational workflows • Lead initiatives to optimize contracting, payment, device logistics, and compliance approval processes • Partner with internal teams and present key updates during Medical Evidence team meetings

🎯 Exigences

• Bachelor's degree with 4+ years of clinical research experience, or an advanced degree with 2+ years of clinical research experience • 5+ years of experience managing or supporting clinical trials within the medical device industry • Experience working on European pre-market studies and managing multiple clinical research sites • Strong knowledge of Good Clinical Practice (GCP), clinical trial regulations, and relevant standards (e.g., CFR 812, CFR 50, CFR 54, ISO 14155) • Fluent in English, with excellent written and verbal communication skills • Ability to manage multiple priorities independently and collaborate effectively within cross-functional teams • Strong problem-solving, organizational, and project management skills, with high attention to detail • Professional and compliant stakeholder management skills, including interactions with healthcare professionals (HCPs), investigators, and internal teams • Willingness and ability to travel up to 20% • Preferred: Experience building and maintaining scientific literature databases • Preferred: Experience with payment processes, contracting, and HCP engagement activities

🏖️ Avantages

• Competitive Salary and flexible Benefits Package • Wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage • Short-term incentive called the Medtronic Incentive Plan (MIP)

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