Central Monitoring Manager

Emploi pas sur LinkedIn

🕒 il y a 4 mois

🇩🇪 Allemagne – Télétravail

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

👔 Manager

👻 Score fantôme 45%

infoinfo

🗣️🇺🇸🇬🇧 Anglais requis

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Logo of PSI CRO AG

PSI CRO AG

1001 - 5000 employés

Fondée en 1996

🏥 Santé

💼 Conseil

📦 Logistique

Healthcare • Consulting • Logistics

PSI CRO AG est une Contract Research Organization (CRO) internationale spécialisée dans la conduite d’essais cliniques. L’entreprise se concentre sur la réalisation d’essais pivots de Phase 2 et 3 dans de multiples aires thérapeutiques, notamment les maladies inflammatoires chroniques de l’intestin, l’oncologie, l’hématologie, les maladies infectieuses, la sclérose en plaques et les maladies rares. PSI s’appuie sur une plateforme technologique propriétaire pour la planification des essais et le suivi financier, garantissant des études menées dans les délais et le budget impartis. L’entreprise est reconnue pour son expertise, sa qualité, sa compatibilité opérationnelle et sa fiabilité, et a reçu à plusieurs reprises les CRO Leadership Awards.

Description

• Lead and facilitate initial and ongoing study Risk Management • Participate in selection and setup of the RBM platform • Perform Centralized Monitoring for a study including review of Key Risk Indicators, Statistical Analyses and Quality Tolerance Limits • Present Centralized Monitoring analysis results to study teams and clients and manage issues in cross-functional environment • Develop and review study-specific Plans • Set up and manage targeted SDV and monitoring strategy for a study • Set up and manage Central Data Review activities in a study • Contribute to Proposals and bid defense meetings with information about Risk Based Monitoring services • Communicate study challenges to Clinical Data Science group and work out data-driven solutions

🎯 Exigences

• College/University degree or an equivalent combination of education, training and experience • Clinical Study Lead/Manager experience • Strong communication & presentation skills are essential • Leadership and ability to work independently are essential • Centralized Monitoring experience is a plus • Critical thinking and analytical skills • Ability to work with complex data and provide insight into risk reports and trends • Ability to adapt to changing circumstances and learn quickly • Knowledge of the process and functions in clinical trials, ability to understand the protocol and study associated risks • Full working proficiency in English (German proficiency is a plus) • Proficiency in MS Office applications, Excel skills

🏖️ Avantages

• Excellent and flexible working conditions. • A unique combination of team collaboration and independent work. • Competitive salary and benefits package.

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