Global Study Manager

Emploi pas sur LinkedIn

🕒 il y a 8 mois

🌐 Espagne, Hongrie, +3 autres pays – Distant

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⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

👔 Manager

👻 Score fantôme 45%

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🗣️🇺🇸🇬🇧 Anglais requis

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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

• Support the planning, setup, execution, and close-out of global clinical studies. • Oversee vendors and country teams to ensure smooth study delivery. • Work closely with AstraZeneca’s internal teams and external partners. • Help develop and update study documents (e.g., protocols, informed consent forms). • Manage third-party vendors, including contracts and budgets. • Ensure all study activities comply with regulations (ICH-GCP), AstraZeneca SOPs, and best practices. • Contribute to meetings, audits, and inspections. • Support risk management and quality assurance efforts. • Maintain accurate study documentation and ensure inspection readiness at all times.

🎯 Exigences

• Bachelor’s degree (preferably in life sciences or related field). • At least 5 years’ experience in clinical research, with 3+ years in Global clinical project management/ Global Study Manager within a Pharma or CRO • Strong knowledge of clinical research regulations (ICH-GCP). • Proven ability to deliver projects on time, within budget, and to quality standards. • Experience working with internal teams and external vendors including vendor set up, management and vendor budgets. (eg. central labs, IRT etc) • Excellent communication, teamwork, and problem-solving skills. • Ability to manage multiple priorities and work in a matrix environment. • Experience in all phases of clinical study lifecycle. • Experience in haematology or oncology studies in early phase • Experience in using AI automation in your daily work as a GSM • Knowledge of GXP outside of GCP (e.g., GMP, GLP). • Desirable: Advanced degree (MSc, PhD).

🏖️ Avantages

• Various annual leave entitlements • A range of health insurance offerings to suit you and your family’s needs. • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. • Life assurance • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

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