Manager, Global Clinical Monitoring

🕒 il y a 29 jours

🇵🇱 Pologne – Télétravail

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

👔 Manager

👻 Score fantôme 11%

infoinfo

🗣️🇺🇸🇬🇧 Anglais requis

🗣️🇵🇱 Polonais requis

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Logo of Precision For Medicine

Precision For Medicine

1001 - 5000 employés

🏥 Santé

💼 Conseil

📦 Logistique

💰 €75 000 000 Private Equity Round en 2015-12

Healthcare • Consulting • Logistics

Precision for Medicine est un leader spécialisé dans l’accompagnement du développement et de la mise sur le marché de thérapies innovantes, notamment en oncologie, dans les maladies rares et les maladies auto-immunes. Grâce à une gamme complète de services — gestion d’essais cliniques, services de laboratoire et collecte de biospécimens — l’entreprise intègre des capacités avancées en biomarqueurs ainsi que des solutions de fabrication pour fluidifier des processus de développement clinique complexes. Sa mission est d’accélérer la recherche et d’apporter aux patients des solutions médicales qui changent la vie, en dépassant les inefficacités traditionnelles souvent observées dans le paysage du développement pharmaceutique.

Description

• Provide line management to CRAs, IHCRAs and CTMs across assigned European countries, driving performance, engagement, accountability and career growth • Generate action plans and provide strategic oversight to optimize clinical operations performance and delivery • Partner with Clinical Operations leadership and project teams on resource allocation, utilization and deployment • Perform accompanied site visits to assess CRA competencies, identify development opportunities and provide coaching • Identify quality risks, performance concerns and operational challenges; implement and monitor corrective and preventive actions • Ensure staff have necessary resources, training, tools, systems access and support • Monitor workforce performance metrics and trends to support decision-making, workforce planning and operational excellence • Ensure timely completion of administrative, compliance and training activities • Lead or participate in departmental, regional and global process improvement, standardization, digital enablement and workforce development initiatives • Develop and drive solutions improving quality, efficiency, employee experience and business performance • Participate in recruitment, selection, onboarding and integration of new CRAs, IHCRAs and CTMs • Foster collaboration, continuous learning, accountability and high performance • Represent Precision for Medicine with internal stakeholders, clients and external partners • Perform other duties and special projects as assigned

🎯 Exigences

• Degree or equivalent experience, ideally in a scientific, life sciences or healthcare discipline • Fluency in English and Polish • Strong clinical operations experience within a CRO, biotechnology or pharmaceutical environment, including prior onsite monitoring experience • Demonstrated direct line management experience leading CRAs and/or other clinical operations professionals • Demonstrated experience coaching, developing and managing employee performance • Strong knowledge of ICH-GCP, applicable regulatory requirements and clinical trial conduct • Ability to work independently, solve problems proactively and drive successful outcomes • Willingness and ability to travel domestically and internationally, including overnight travel, up to approximately 25% • Experience with clinical research systems and technology, including EDC, EMR and other clinical trial management tools

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