Manager, Global Clinical Monitoring

đź•’ vor 18 Tagen

🇵🇱 Polen – Remote

⏰ Vollzeit

🟡 Mittelstufe

đźź  Senior

đź‘” Manager

đź‘» Geisterscore 21%

infoinfo

🗣️🇺🇸🇬🇧 Englisch erforderlich

🗣️🇵🇱 Polnisch erforderlich

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Logo of Precision Medicine Group

Precision Medicine Group

1001 - 5000 Mitarbeiter

GegrĂĽndet 2012

đź’Ľ Beratung

🏥 Gesundheitswesen

📦 Logistik

💰 €35.200.000 Venture Round im 2021-03

Consulting • Healthcare • Logistics

Precision Medicine Group ist ein globales Expertenteam, das sich auf Präzisionsmedizin spezialisiert – eine Disziplin, die fortgeschrittene Laborwissenschaften, translationale Informatik, Regulatory Affairs, Payer Insights und Marketingkommunikation verbindet. Das Unternehmen konzentriert sich darauf, Herausforderungen in der Produktentwicklung und Kommerzialisierung für Kunden aus der Pharma- und Life-Sciences-Branche zu bewältigen. Die Services umfassen biomarkergetriebene Forschung und Entwicklung sowie Unterstützung bei der Kommerzialisierung für Life-Science-Organisationen – vom Launch bis zur Produktreife. Die Precision Medicine Group agiert über zwei Hauptgeschäftsbereiche: Precision for Medicine und Precision AQ, die jeweils auf klinische bzw. kommerzielle Lösungen spezialisiert sind.

Beschreibung

• 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 quality delivery • Partner with Clinical Operations leadership and project teams on resource allocation, utilization and deployment across projects and countries • Perform accompanied site visits to assess CRA competencies, identify development opportunities and provide coaching • Identify quality risks, performance concerns and operational challenges, implementing corrective and preventive actions • Ensure staff have required 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 that enhance quality, efficiency, employee experience and business performance • Participate in recruitment, selection, onboarding and integration of CRAs, IHCRAs and CTMs • Foster collaboration, continuous learning, accountability and high performance • Represent Precision for Medicine professionally to internal stakeholders, clients and external partners • Perform other duties and special projects assigned by leadership • Contribute to the development and execution of targeted, adaptive clinical trials that use biomarkers and molecular-level insights to optimize oncology development pathways

🎯 Anforderungen

• 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% • Proficiency with clinical research systems and technology, including EDC, EMR and other clinical trial management tools • Preferred: experience managing CRAs, IHCRAs and/or CTMs across multiple countries or regions • Preferred: oncology clinical research experience • Preferred: experience supporting process improvement, operational excellence or organizational change initiatives • Preferred: experience in resource planning and workforce management within a matrix environment • Preferred: track record of leading cross-functional or departmental initiatives beyond core line management responsibilities • Strong people leadership, coaching, emotional intelligence and team-development capability • Excellent organizational, prioritization and problem-solving skills • Strong understanding of clinical trial operations and site, study and operational challenges • Effective collaboration and influencing skills • Excellent verbal, written, presentation and stakeholder communication skills • Commitment to continuous improvement, quality, accountability and operational excellence • Professionalism, integrity and work ethic aligned with company values • Please apply in English

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