Senior Clinical Research Manager (In-House), Oncology

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn. The In-house Sr. Clinical Research Manager, will oversee the day-to-day functions of assigned Site Monitors (SM) to ensure the monitoring team is meeting established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. The In-house Sr. Clinical Research Manager works collaboratively with internal and external team members and supports project team activities to ensure all study deliverables are completed on time and within budget. The In-house Sr. Clinical Research Manager will oversee clinical site management performed by the Lead Clinical Research Associate (CRA) and site monitors. Key Responsibilities: u00b7 Supports the Director of Clinical Operations in management of Site Monitoring Team relating to regular timesheet and expense approvals. u00b7 Assists the Director of Clinical Operations in periodic and annual budget forecasting for site monitoring across programs. u00b7 Supports implementation of global initiatives to ensure monitoring training and conduct are consistent. u00b7 Participates in and may facilitate cross-functional study teams, liaise with other functional areas to coordinate clinical study monitoring-related activities. u00b7 Coordinates with study project leads on clinical study timelines to meet critical milestones; escalate monitoring-related issues that may jeopardize timelines and deliverables. u00b7 Provides monitoring oversight by reviewing monitoring schedules, metrics and reports. u00b7 May review monitoring visit reports; liaise with monitors to understand any trends on quality issues or other site issues to develop solutions. Provides regular updates of study monitoring progress; proactively identifies and resolves issues that arise during study conduct; manages escalation of monitoring-related issues. u00b7 Participates in development and review of study plans; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study documents. u00b7 Implements appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance. u00b7 Provides oversight of monitoring-related site level TMF document collection and filing, as well as collaboration with project-specific TMF Specialist to ensure inspection readiness of the TMF. u00b7 Contributes to study feasibility assessments and selection of countries and sites for study conduct. u00b7 Works with Lead CRA to develop monitoring training and may conduct internal/external training sessions including investigator meetings u00b7 All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company SOP's. u00b7 Mentorsu2019 junior members of the team. u00b7 Performs other duties as assigned. Professional Experience/Qualifications: u00b7 Minimum of 6 years CRA experience in the pharmaceutical/biotech industry. u00b7 Bachelors Degree Required. u00b7 Must have strong knowledge of ICH/GCP guidelines. u00b7 Comprehensive understanding of the drug development process. u00b7 Prior oncology drug development experience preferred. u00b7 Adept at working with a cross-functional project team. u00b7 Strong interpersonal, communication and leadership skills. u00b7 Proficient with MS office suite. u00b7 High level of organizational skills. u00b7 Demonstrated ability to work independently in a matrix environment. u00b7 Demonstrated ability to prioritize and manage multiple tasks simultaneously. u00b7 Demonstrated ability to influence through collaboration. u00b7 Flexibility to accommodate changes in priorities and project needs. u00b7 This position is not an onsite monitoring position but may require travel The base salary range for this role is $137,800 to $172,300. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Confidential Data : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. Compliance : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the

Created: 2026-02-13