Senior Clinical Research Manager, Oncology

Join Sumitomo Pharma Co., Ltd., a leading global pharmaceutical company dedicated to advancing patient care in oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS. We’re committed to expediting the discovery and development of innovative therapies to enhance patient health. Explore more about us on our website or connect with us on LinkedIn. As a Senior Clinical Research Manager, you will play a crucial role in overseeing the daily functions of Site Monitors, ensuring that our monitoring team meets project goals while adhering to GCP/ICH guidelines and regulatory standards. Your role will involve collaboration with both internal and external team members to facilitate timely completion of study deliverables within budget parameters. You will supervise clinical site management led by the Lead Clinical Research Associate (CRA) and site monitors. Key Responsibilities: Support the Director of Clinical Operations in managing the Site Monitoring Team, including timesheet and expense approvals. Assist in budget forecasting for site monitoring across various programs. Implement global initiatives to standardize monitoring training and practices. Collaboration with cross-functional study teams to coordinate monitoring-related activities. Coordinate clinical study timelines with project leads to meet critical milestones and escalate potential monitoring-related issues. Provide oversight by reviewing monitoring schedules, metrics, and reports. Review monitoring visit reports and liaise with monitors to identify trends and resolve quality or site issues. Be involved in the development and evaluation of study plans and essential documents. Establish systems and standards to ensure quality at investigative sites, vendors, and data management. Oversee the collection and organization of monitoring-related site-level TMF documents for inspection readiness. Contribute to study feasibility assessments and the selection of countries and sites for studies. Work with Lead CRA to develop and possibly lead monitoring training sessions. Mentor junior team members and perform other duties as assigned. Professional Experience/Qualifications: A minimum of 6 years of CRA experience in the pharmaceutical or biotech industry. Bachelor's Degree required. Strong understanding of ICH/GCP guidelines and the drug development process; oncology experience preferred. Excellent interpersonal, communication, and leadership skills. Proficiency in MS Office Suite and strong organizational abilities. Demonstrated ability to work independently in a matrix environment and manage multiple tasks effectively. Flexibility to adjust priorities and project needs as they arise. This position does not involve on-site monitoring but may require travel. The base salary range for this role is $137,800 to $172,300, with merit-based salary increases and a comprehensive benefits package, including medical, dental, vision, life insurance, and more. Our time-off policy includes flexible paid time off, holidays, and sick leave. Compliance: Ensure adherence to all applicable regulatory, legal, and operational standards by conducting activities with the highest ethical practices. Mental/Physical Requirements: This role requires the ability to manage a fast-paced environment with multiple demands, effective judgment, and independence. Equal Employment Opportunity: Sumitomo Pharma America is an equal opportunity employer and welcomes applicants without regard to race, color, religion, national origin, age, sex, gender identity, sexual orientation, disability, or veteran status. If you require assistance with the application process, please contact us. Please note, this contact is for accommodation requests only.

Created: 2026-03-04