Senior Clinical Trial Manager

Job Description

Senior Clinical Trial Manager

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· Home-based within the United States; East Coast preferred

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· Minimum 5 years of clinical trial management experience; 8+ years preferred

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· Minimum 3 years of sponsor-side oversight of CRO operations on EU studies

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· Oncology or hematology clinical trial experience strongly preferred

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· Daily early-morning availability for collaboration with EU teams and sites

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Newave 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.

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Description

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SCHEDULE: Full-time

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Work Location:

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**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.

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Duties

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• Provide day-to-day management of the CRO's EU operations, including performance monitoring, issue escalation, and participation in governance and operational meetings
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• 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
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• Monitor site performance, activation, enrollment, patient retention, and data quality across EU investigational sites in compliance with applicable EU regulations and ICH-GCP
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• Prepare 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
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• Review and validate CRO and vendor invoices and support Finance with reconciliation for the EU portion of the study
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• 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
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• 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
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• Maintain and review EU-specific trial and vendor documentation to support ongoing inspection readiness
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• Work closely with global Clinical Operations, Data Management, Regulatory, Finance, CMC, Medical, and the CRO on both EU-specific and global study deliverables
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• Develop and maintain operational plans, timelines, status reports, risk logs, and mitigation actions, and communicate material issues and decisions promptly
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• Perform other duties as required to support successful delivery of the global Phase 3 program
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Qualifications

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You should have:

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

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• An advanced degree in life sciences, medicine, pharmacy, or a related field
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• Working knowledge of one or more European languages
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• Prior CRA experience
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• Experience mentoring and/or training less senior clinical operations team members
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We 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.

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We are an equal opportunity employer and value diversity at our company. We do not discriminate based on any legally protected characteristic.

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Notice

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Our 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.