Senior Study Start-Up Manager

Role: Senior Clinical Trial Start-Up (SSU) Lead responsible for managing the initiation and regulatory submission activities of oncology or broader clinical studies across the Americas. Objectives include ensuring timely, high-quality site activation and regulatory compliance per ICH/GCP standards. Responsibilities: oversee site feasibility, study start-up, IRB setup, and submission processes; drive process improvements; manage resource allocation; and lead a team for site identification, activation, and documentation submission. Qualifications: bachelor’s degree in a scientific or healthcare field; 7+ years in clinical research with experience in biotech, pharma, or CRO environments; strong understanding of ICH/GCP, site engagement, and regulatory submissions. Skills: excellent communication, organization, risk mitigation, and leadership capabilities; proficient in MS Office; experience with FSP model preferred. High-Value Details: focus on clinical trial execution in oncology with potential involvement across phases; leadership in global or regional start-up infrastructure; up to 10% travel; team management experience is required. Work setup involves some travel; leadership and strategic input within the clinical operations framework.