Senior Site Activation Manager

🕒 vor 3 Tagen

🌲 North Carolina – Remote

infoinfo

💵 $107.000 - $213.000 / Jahr

⏰ Vollzeit

🟠 Senior

👔 Manager

🗣️🇺🇸🇬🇧 Englisch erforderlich

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Logo of Worldwide Clinical Trials

Worldwide Clinical Trials

1001 - 5000 Mitarbeiter

🏥 Gesundheitswesen

💼 Beratung

📦 Logistik

Healthcare • Consulting • Logistics

Worldwide Clinical Trials ist eine globale Auftragsforschungsorganisation (CRO) und bietet umfassende Dienstleistungen für klinische Studien. Das Unternehmen ist auf die Unterstützung von Studien in verschiedenen Therapiegebieten wie Onkologie, Kardiologie und seltenen Erkrankungen spezialisiert. Mit über 30 Jahren Erfahrung legt Worldwide Clinical Trials Wert auf persönliche Betreuung und maßgeschneiderte Lösungen über den gesamten Lebenszyklus der Arzneimittelentwicklung hinweg. Zum Serviceportfolio zählen unter anderem klinisches Monitoring, Data Management, Patient Recruitment sowie Regulatory Consulting – für Präzision und individuelle Aufmerksamkeit in jeder klinischen Studie.

Beschreibung

• 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

🎯 Anforderungen

• 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

🏖️ Vorteile

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

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