Sr. Clinical Trial Manager (CTM), Late Phase EU Metabolic Studies - Region Lead

Description:
Remote

Our client seeks a Senior Clinical Trial Manager to lead sponsor-side oversight for Phase III global studies across Europe in the MASH therapeutic area. The role will provide regional leadership of fully outsourced studies, manage EU submissions, oversee site activation, and guide two sponsor-side CTMs assigned to specific countries. The CTM will drive governance with the CRO, ensure quality and compliance, and collaborate with cross-functional teams to meet timelines. The position reports to the Clinical Operations Program Lead.

Due to client requirements, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance.

Rate: $95.00 to $105.00/hr. w2

Responsibilities:

• Provide comprehensive oversight of CRO performance, deliverables, and timelines.
• Lead study governance meetings and ensure clear communication of expectations.
• Identify and proactively mitigate operational risks.
• Monitor study progress, enrollment, and key performance indicators.
• Support protocol drafting, review, and finalization to ensure timely completion.
• Coordinate cross-functional review of study protocols and related documents.
• Ensure alignment between sponsor and CRO during start-up activities.
• Oversee development of key study documents including monitoring plans, study plans, and vendor plans.
• Track and manage study timelines and milestones.
• Review essential study documents and reports for quality and compliance.
• Oversee site activation and ensure readiness for first patient in.
• Collaborate with Regulatory, Data Management, Safety, and Clinical Operations.
• Escalate issues appropriately and provide solutions to maintain timelines.
• Execute trip report review and protocol deviation review.
• Manage EU region submissions and provide regional leadership of outsourced studies.
• Oversee two sponsor-side CTMs assigned to specific countries for site management and operational oversight.

Experience Requirements:

• 8 to 10+ years of progressive clinical research experience primarily on the sponsor side.
• Senior Clinical Trial Manager or equivalent sponsor-side study lead experience.
• Late Phase (Phase III) clinical trial oversight experience.
• Experience overseeing outsourced studies running at sites in Europe.
• Experience overseeing fully outsourced studies through CRO partners.
• Therapeutic area experience in MASH, metabolic diseases, liver disease, or chronic kidney disease preferred.
• Strong understanding of Google Cloud Platform.
• Organizational, leadership, and cross-functional communication skills.

Education Requirements:
Bachelor's Degree.

Recruitment Transparency Notice



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Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range.

W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality.
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About Eliassen Group:

Eliassen Group is a strategic consulting firm that helps organizations reach further and achieve more through our technology, business advisory, and life sciences solutions. For nearly 40 years, we have combined exceptional people, deep domain expertise, and intelligent capabilities to expand our clients' capacity and accelerate meaningful outcomes. We are driven by a purpose to positively impact the lives of our employees, clients, consultants, and the communities we serve.

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