Manager, Regulatory Operations

The START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. Throughout our history, START has provided hope to cancer patients in global community practices by offering "Hope Through Access” to cutting edge trials throughout the United States and Europe. We are seeking a Manager, Regulatory Operations (Remote). This role performs operational leadership for the Regulatory Operations function across START USA. This role leads and develops a team that includes Specialists), and Assistants to ensure timely, accurate, and compliant regulatory submissions and maintenance of inspection-ready Investigator Site Files (ISFs). The Manager, Regulatory Operations is accountable for team performance, process standardization, metrics, training and onboarding, and continuous improvement of systems and workflows supporting IRB, IBC, and FDA interactions, in alignment with applicable regulations and guidelines (e.g., GCP, FDA BIMO, 21 CFR Part 11). The annual base salary for this role is $110,000 - $135,000. However, base pay may vary depending on multiple individualized factors including market location, job-related knowledge, skills, and experience. Work Schedule: Monday-Friday 8:00am-5:00pm Location: Remote Essential Responsibilities: Provide direct people leadership for assigned team. Partner with the Regulatory Operations Leadership and Quality Assurance to set departmental goals and ensure timely execution