Descrição do Perfil

he Global Study Manager is a member of the extended global study team, supporting the delivery of clinical studies within Cell Therapy Clinical Operations to agreed timelines, cost and quality standards, from Clinical Study Protocol development through study set-up, maintenance, close-out, Clinical Study Report development and archiving.The role works cross-functionally with internal and external partners and supports the Global Study Director and/or Global Study Associate Director in delegated aspects of clinical study execution.Responsibilities include preparation and coordination of study documentation, management of interactions with CROs and other external service providers, support for internal and external study meetings, coordination of investigational products and study materials, and identification and management of study risks and issues.The role ensures study documentation is complete and quality-verified within the Trial Master File, supports budget management and invoice reconciliation, and contributes to overall project management. For outsourced studies, the role supports oversight of the CRO Project Manager to ensure delivery according to timelines, budget and quality standards.The role operates in accordance with global clinical processes, SOPs, quality and compliance requirements and ICH/GCP guidelines, ensuring inspection readiness.Candidates should have a university degree or equivalent, preferably in medical or biological sciences or a discipline related to clinical research, and at least 3 years of relevant experience. Knowledge of clinical/drug development and ICH/GCP, project management, communication, collaboration and leadership skills, computer proficiency and excellent written and spoken English are required.