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 sites

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.

Description

SCHEDULE: Full-time

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-GCP
• 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
• 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

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.

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

Notice

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.

Pay: $155,000.00 - $190,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Paid time off
• Retirement plan
• Vision insurance

Application Question(s):

• How many years of clinical trial management experience do you have?
• How many years of sponsor-side experience do you have overseeing CRO operations for clinical studies conducted in Europe?
• Are you currently located in the United States and able to work remotely from the U.S.?
• Are you available for daily early-morning collaboration with EU teams and sites, as well as occasional late-day calls with the U.S. Pacific team?
• Do you have a bachelor’s degree or higher in life sciences, medicine, pharmacy, or a related field?
• Have you personally led EU site start-up activities, including site budget/contract review and coordination of informed consent forms and regulatory submissions?
• Do you have clinical trial experience in oncology or hematology?
• Have you managed study-budget forecasts, CRO/vendor invoice review, and eTMF inspection readiness?
• Are you legally authorized to work in the United States?

Work Location: Remote