Senior Site Activation Manager

🕒 il y a 3 jours

🌲 North Carolina – Distant

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💵 $107 000 - $213 000 / an

⏰ Temps Plein

🟠 Senior

👔 Manager

🗣️🇺🇸🇬🇧 Anglais requis

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Logo of Worldwide Clinical Trials

Worldwide Clinical Trials

1001 - 5000 employés

🏥 Santé

💼 Conseil

📦 Logistique

Healthcare • Consulting • Logistics

Worldwide Clinical Trials est une organisation mondiale de recherche contractuelle (CRO) qui offre des services complets d'essais cliniques. Ils se spécialisent dans le soutien aux études dans divers domaines thérapeutiques tels que l'oncologie, la cardiologie et les maladies rares. Avec plus de 30 ans d'expérience, Worldwide Clinical Trials met l'accent sur un soutien personnalisé et des solutions sur mesure tout au long du cycle de développement des médicaments. Leurs services incluent la surveillance clinique, la gestion des données, le recrutement de patients et le conseil réglementaire, garantissant précision et attention sur-mesure pour chaque essai clinique.

Description

• Lead and oversee study start-up and site activation activities for assigned projects • Drive cross-functional collaboration to complete site activation milestones and deliverables on time and within budget • Manage and analyze site activation metrics, identify risks, and implement mitigation plans • Partner with project teams on site qualification, selection, regulatory, and essential document collection activities • Communicate project status, timelines, risks, and outcomes to sponsors, project leadership, and internal stakeholders • Track and maintain site activation activities, budgets, and change management requirements • Contribute to proposals, budgets, bid defense activities, and business development initiatives • Coach and mentor Site Activation Managers • Support SOP development, best practices, and continuous process improvement • Ensure compliance with ICH GCP, applicable regulations, SOPs, and study-specific requirements

🎯 Exigences

• Bachelor's degree in a medical, biological, physical, health, pharmacy, or related science field, or a two-year degree plus four years of clinical research experience • Seven or more years of CRO and/or pharmaceutical industry experience • Experience preferably in Start-up Management, Project Management, and/or Site Management • Strong leadership, organizational, and project management skills • Thorough understanding of site activation processes, clinical project planning and execution, and country- or region-specific regulatory requirements • Strong knowledge of ICH GCP guidelines, FDA/EU Clinical Trials Directives, and national regulatory requirements • Ability to make independent decisions, solve complex problems, and manage risk • Collaboration, communication, mentoring, and stakeholder-management skills across global and cross-cultural teams • Proficiency in spoken and written English

🏖️ Avantages

• Competitive benefits package depending on location • Inclusive and equitable workplace • Growth and professional development opportunities • Collaborative and inclusive environment

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