Senior Clinical Trial Manager

Senior Clinical Trial Manager· Home-based within the United States; East Coast preferred· Minimum 5 years of clinical trial management experience; 8+ years preferred· Minimum 3 years of sponsor-side oversight of CRO operations on EU studies· Oncology or hematology clinical trial experience strongly preferred· Daily early-morning availability for collaboration with EU teams and sitesNewave Pharmaceutical Inc. (Newave) is looking to hire a full-time Senior Clinical Trial Manager  in the United States (remote, work from home). Newave Pharmaceutical Inc. is a commercial-stage biotechnology company headquartered in Pleasanton, California, focused on developing innovative small-molecule therapies in hematological malignancies and autoimmune diseases. DescriptionSCHEDULE: Full-timeWork 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.DutiesProvide day-to-day management of the CRO's EU operations, including performance monitoring, issue escalation, and participation in governance and operational meetingsLead 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 documentsMonitor 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 variancesReview and validate CRO and vendor invoices and support Finance with reconciliation for the EU portion of the studyPartner with the EU regulatory team and internal medical team on submissions and approvals to prevent country and site activation from being delayed by regulatory timelinesAuthor 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 filingMaintain and review EU-specific trial and vendor documentation to support ongoing inspection readinessWork closely with global Clinical Operations, Data Management, Regulatory, Finance, CMC, Medical, and the CRO on both EU-specific and global study deliverablesDevelop and maintain operational plans, timelines, status reports, risk logs, and mitigation actions, and communicate material issues and decisions promptlyPerform other duties as required to support successful delivery of the global Phase 3 programQualificationsYou should have:Bachelor's degree in life sciences, medicine, pharmacy, or a related fieldMinimum 5 years of clinical trial management experience; 8 or more years preferredAt least 3 years of sponsor-side experience overseeing CRO operations on EU clinical studiesOncology or hematology clinical trial experience strongly preferredWorking knowledge of applicable EU clinical trial regulations, ICH/GCP guidelines, and EU data protection requirementsDemonstrated experience with CRO oversight, site start-up and contracts, site performance oversight, budget forecasting, invoice review, and regulatory coordinationExperience authoring, reviewing, and managing clinical trial documents and maintaining eTMF inspection readinessAvailability for daily early-morning collaboration with the EU CRO team and EU sites, plus occasional late-day U.S. Pacific calls with the global teamStrong leadership, communication, problem-solving, organizational, and cross-functional collaboration skillsAbility to work effectively in a fast-paced biotechnology company, respond to issues promptly, and contribute towards global decisions under the advisor roleAbility to travel as neededIt would be helpful if you had:An advanced degree in life sciences, medicine, pharmacy, or a related fieldWorking knowledge of one or more European languagesPrior CRA experienceExperience mentoring and/or training less senior clinical operations team membersWe would love to talk to you about this opportunity. If you are highly qualified, you will hear from one of our recruiters. We are actively interviewing, so apply today.We are an equal opportunity employer and value diversity at our company. We do not discriminate based on any legally protected characteristic.NoticeOur Company's recruiters take the candidate experience very seriously. During recruitment, no recruiter or employee will request financial or personal information by email. Our recruiters will not email you from a public webmail service such as Gmail or Yahoo Mail.