Trial Committee Manager

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PSI CRO AG

Site WebLinkedInTous les Emplois

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

• Manage the full lifecycle of clinical trial committees, from committee setup and member selection through study conduct and close-out • Coordinate committee meetings, communications, recommendations, and follow-up activities throughout clinical trials • Develop, maintain, and update committee charters, procedures, and trial-specific documentation • Identify, evaluate, and engage qualified external committee members based on study requirements, expertise, availability, and independence criteria • Perform Fair Market Value assessments and prepare honorarium estimates for independent committee members • Support audits and inspections related to committee management activities and contribute to corrective and preventive actions • Contribute to the development and continuous improvement of committee-related quality documentation, business processes, templates, and training materials • Support the planning and delivery of internal training on committee management processes • Coordinate sponsors, committee members, and cross-functional PSI teams to ensure efficient, compliant, high-quality committee activities • Collaborate with global project teams and external experts to support clinical trial delivery across therapeutic areas

🎯 Exigences

• Bachelor's degree in Life Sciences, Pharmacy, Healthcare, Clinical Research, or a related field • At least 3 years of experience in clinical research, preferably within a CRO environment • Experience managing or coordinating clinical trial committees or comparable clinical trial management experience with exposure to committee processes • Proven project management and stakeholder coordination skills • Ability to manage multiple priorities in a fast-paced environment • Strong organizational, communication, and problem-solving skills • Exceptional attention to detail • Ability to build effective working relationships with sponsors, external experts, and cross-functional teams • Professional proficiency in English, written and spoken • Proficiency in Microsoft Office applications and virtual meeting platforms

🏖️ Avantages

• Remote work option • Collaborative, globally connected team • Opportunities to grow, contribute, and make a meaningful impact on global healthcare