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The Senior Study Manager will be responsible for ensuring the delivery and execution of clinical studies across multiple geographic regions. This role requires adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), FDA regulations/EU Directives, and ICH guidelines. The incumbent will interact routinely with key internal and external stakeholders to communicate project status, escalate issues, and troubleshoot inquiries. The role involves managing clinical study plans, overseeing CROs and vendors, and ensuring study milestones are achieved within timelines and budget.