Senior Clinical Trial Manager

Work Location: **This is a work-from-home position, and candidates may be located anywhere in the United States. East Coast candidates are preferred to support daily collaboration with EU sites, the CRO, and global internal functions.

Duties: Provide day-to-day management of the CRO's EU operations, including performance monitoring, issue escalation, and participation in governance and operational meetings Lead EU site start-up activities, including site budget and contract review and negotiation, informed consent form review and approval, and review and approval of submission documents Monitor site performance, activation, enrollment, patient retention, and data quality across EU investigational sites in compliance with applicable EU regulations and ICH-GCPPrepare and maintain the EU portion of the quarterly study budget forecast for integration into global Phase 3 whole-study budget planning; track actuals against forecast and explain variances Review and validate CRO and vendor invoices and support Finance with reconciliation for the EU portion of the study Partner with the EU regulatory team and internal medical team on submissions and approvals to prevent country and site activation from being delayed by regulatory timelines Author and review clinical trial documents, including protocols and amendments, informed consent forms, site-facing materials, and IRB/EC and health authority correspondence; coordinate review and approval through internal & external document repositories and assist oversight of eTMF filing Maintain and review EU-specific trial and vendor documentation to support ongoing inspection readiness Work closely with global Clinical Operations, Data Management, Regulatory, Finance, CMC, Medical, and the CRO on both EU-specific and global study deliverables Develop and maintain operational plans, timelines, status reports, risk logs, and mitigation actions, and communicate material issues and decisions promptly Perform other duties as required to support successful delivery of the global Phase 3 program

Qualifications: You should have:

• Bachelor's degree in life sciences, medicine, pharmacy, or a related field
• Minimum 5 years of clinical trial management experience; 8 or more years preferred
• At least 3 years of sponsor-side experience overseeing CRO operations on EU clinical studies
• Oncology or hematology clinical trial experience strongly preferred
• Working knowledge of applicable EU clinical trial regulations, ICH/GCP guidelines, and EU data protection requirements
• Demonstrated experience with CRO oversight, site start-up and contracts, site performance oversight, budget forecasting, invoice review, and regulatory coordination
• Experience authoring, reviewing, and managing clinical trial documents and maintaining eTMF inspection readiness
• Availability for daily early-morning collaboration with the EU CRO team and EU sites, plus occasional late-day U.S. Pacific calls with the global team
• Strong leadership, communication, problem-solving, organizational, and cross-functional collaboration skills
• Ability to work effectively in a fast-paced biotechnology company, respond to issues promptly, and contribute towards global decisions under the advisor role
• Ability to travel as needed
• It would be helpful if you had:
• An advanced degree in life sciences, medicine, pharmacy, or a related field
• Working knowledge of one or more European languages
• Prior CRA experience
• Experience mentoring and/or training less senior clinical operations team members