Job Title: Senior Clinical Study Manager

The Senior Clinical Study Manager is responsible for ensuring the successful execution and delivery of clinical studies across various geographic regions, adhering to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), FDA regulations, EU Directives, and ICH guidelines. This role requires extensive interaction with internal and external stakeholders to communicate project status, address issues, and provide expert-level guidance. The position reports to an Associate Director and involves both strategic planning and operational execution of clinical studies.

Responsibilities

• Lead the development of clinical study plans, identifying critical path activities and interdependencies.
• Create and manage the Clinical Study Oversight Plan, ensuring adherence and documentation of activities by CROs and vendors.
• Provide operational input into study protocols and amendments, and lead document review and coordination.
• Oversee CRO and vendor selection, scope of work creation, and ensure compliance with quality measures and timelines.
• Monitor clinical trial performance and quality metrics, escalating issues and proposing solutions as necessary.
• Ensure study adherence to internal procedures for planning, conduct, close out, and reporting.
• Monitor and reconcile study budgets, reviewing vendor invoices and ensuring alignment with Finance.
• Coordinate study-related meetings and training sessions, including vendor kick-off and investigator meetings.
• Support department in codifying knowledge and best practices, and prepare training materials.

Additional Skills & Qualifications

• 7+ years of experience as a GLOBAL Clinical Trial Manager with a pharmaceutical or biotech company.
• 5+ years of global experience within oncology (SOLID TUMORS!)
• Bachelor of Science degree or higher.
• Experience leading Phase II or III global studies within oncology
• Experience working for a Japanese company is a plus.

Work Environment

The team consists of a team lead and three study managers, with responsibilities in vendor management and regional assignments. The team operates in either the EU or US-Latin America regions, managing timelines, budgets, site activation, and enrollment. The role requires experience in study management, global experience, and overseeing CROs for study management activities.