Clinical Trial Manager

Role: Clinical Trial Manager overseeing a global Phase 3 oncology trial, focusing on vendor management, project planning, and regulatory compliance. Responsibilities include leading cross-functional teams, managing vendor relationships (CROs, IRT, eTMF), coordinating study setup, monitoring progress, and ensuring trial quality and adherence to GCP and SOPs. Key tasks involve contract negotiations, study-specific document development, site selection, oversight of data management, and risk mitigation. The role also encompasses budget forecasting, audit readiness, and collaboration with medical, data, and quality teams. Requirements: BA/BS in a scientific or healthcare field, minimum of 3 years’ clinical trial experience with demonstrated management of Phase 3 oncology studies, strong knowledge of ICH and GCP guidelines, excellent communication skills, and ability to multitask. Travel may be required. HighValue: global Phase 3 oncology trial, experience in oncology, vendor and contract management, regulatory compliance, cross-functional leadership, study lifecycle oversight, and experience working with CROs and regulatory agencies.