Senior Clinical Research Associate

🔥 il y a 9 heures

🇭🇺 Hongrie – Télétravail

⏰ Temps Plein

🟠 Senior

🧪 Chercheur Clinique

👻 Score fantôme 10%

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🗣️🇺🇸🇬🇧 Anglais requis

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Logo of AbbVie

AbbVie

10 000+ employés

Fondée en 2013

🏥 Santé

💼 Conseil

🏭 Fabrication

Healthcare • Consulting • Manufacturing

AbbVie est une entreprise pharmaceutique mondiale qui découvre et fournit des médicaments et des solutions innovants pour améliorer les vies. Axée sur le traitement des défis de santé les plus difficiles au monde, AbbVie opère dans plus de 175 pays, offrant une large gamme de produits dans des domaines tels que l'immunologie, l'oncologie, les neurosciences et les soins esthétiques. Engagée dans l'innovation scientifique, AbbVie investit massivement dans la recherche et le développement, visant à produire des médicaments de premier ordre. L'entreprise met également l'accent sur la diversité au sein du lieu de travail, la durabilité et les initiatives de soutien aux patients, assurant un impact positif tant pour ses patients que pour la communauté au sens large.

Description

• Ensure successful protocol-level execution of SMM deliverables for assigned sites/studies, including start-up, execution, and close-out • Conduct monitoring visits, site evaluations, site selection and activation, monitoring close-out, and visit reports • Anticipate and resolve site issues affecting timelines • Maintain current site-specific information in clinical trial management systems • Provide local regulatory and legal requirement expertise • Ensure timely site payments according to clinical study agreements and local requirements • Ensure adherence to regulations, GCPs, ICH Guidelines, SOPs, monitoring plans, and quality standards • Maintain audit and inspection readiness; support audits, inspections, and CAPA preparation • Coach and mentor CRAs and contribute to their development • Serve as country point of contact for CROs when assigned • Participate in or lead global/local task forces and initiatives • Identify training needs and standardize or facilitate global SMM monitor training when assigned • Support onboarding and incorporate lessons learned into monitoring training materials and curricula when assigned • Update country-level planning information in Impact/Tesla when assigned • Collaborate with stakeholders as a global study representative when assigned • Conduct remote data review according to study plans, SOPs, timelines, and objectives when assigned • Provide ongoing site-performance feedback • Build professional and collaborative relationships with peers and site monitors

🎯 Exigences

• Bachelor's or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred • Minimum 3 years of site monitoring experience • Strong analytical and critical thinking skills • Excellent interpersonal skills and clear, persuasive communication • Flexibility and adaptability to changing requirements • Resourcefulness and creativity • Proactive and positive team-player approach • Strong planning and organizational skills • High level of flexibility in a dynamic environment with competing projects and deadlines • Business ethics and integrity • Knowledge of federal and local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie SOPs, and monitoring plans

🏖️ Avantages

• Employees can work remotely • Equal opportunity employer • Veterans/Disabled employment commitment

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