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

Eliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening and hiring process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team ( , ) inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position. All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group's use of these tools, including AI tools, as part of the application and hiring process.

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.
If anyone reaches out to you about an open position connected with Eliassen Group, please ensure that you are working directly with us by confirming the following:

When you work with Eliassen Group, all email communication will come from an Eliassen.com address, never Gmail, Yahoo, etc.

Eliassen Group will never ask you for personal information (home address, bank account, or check routing number) until you have worked with someone clearly associated with Eliassen Group.

If you have any indication of fraudulent activity, please contact .

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.

Eliassen is committed to building a diverse and inclusive team from a variety of backgrounds, perspectives, and skills. We are an Equal Opportunity and Affirmative Action Employer and all employment decisions are based on merit, performance, and business needs. Eliassen does not discriminate on the basis of race, color, gender identity or expression, sexual preference or orientation, sex (including pregnancy, childbirth, and related medical conditions), marital status, creed, religion, physical or mental disability, genetic information, military or veteran status, age, ancestry, national origin, citizenship status, prohibited criminal record inquiries of applicants and employees, or any other category protected by federal, state, or local laws.

Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!