Project Manager - REMS Team - Remote based in the US

thermofisher; USA; Remote; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Thermo Fisher Scientific seeks a senior Program Manager to lead cross-functional delivery of full-service clinical trials in a remote US role.

You will serve as the sponsor's primary contact, manage time, cost, and quality, and ensure compliance with ICH-GCP and regulatory obligations while guiding regional and vendor teams.

Requirements include a Bachelor's degree, 8+ years in relevant work, and 3–5 years REMS experience with full-service trial management.

Qualifikationen

• Bachelor’s degree or equivalent.
• 8+ years experience in relevant work.
• 3–5 years REMS experience and full-service trial management.
• Strong project management, financial and resource planning skills.

Aufgaben

• Act as sponsor’s main project-level contact and manage customer expectations.
• Coordinate cross-functional team and clarify responsibilities and communication routes.
• Oversee scope, milestones, quality, and budget, align resources with the contract.
• Identify risks and issues, drive resolution, maintain escalation pathways.
• Ensure work follows ICH-GCP, regulatory obligations, and study requirements.

Kenntnisse

Project management

Leadership

Communication

Regulatory knowledge

Risk management

Financial planning

Resource planning

Analytical thinking

Ausbildung

Bachelor’s degree

Jobbeschreibung

**Role overview**

Lead cross-functional delivery of full-service clinical trials, serving as the project’s primary sponsor contact and owning performance across time, cost, and quality. The position calls for substantial project management experience and three to five years of REMS experience; full-service trial management experience is expected, with REMS expertise preferred in the source description.

**Responsibilities**

• Act as the sponsor’s main project-level contact and manage customer expectations throughout delivery.
• Coordinate the cross-functional team and clarify responsibilities and communication routes for regional, vendor, or other project leads.
• Oversee scope, milestones, quality, and budget, aligning resources with the contract and managing out-of-scope work and contract changes.
• Identify project risks and issues, drive resolution, and maintain appropriate escalation pathways.
• Ensure project work follows applicable organizational procedures, ICH-GCP, regulatory obligations, and study-specific requirements.

**Requirements**

• Bachelor’s degree or equivalent relevant academic or vocational qualification.
• Experience comparable to eight or more years in relevant work.
• Three to five years of REMS experience and experience managing full-service clinical trials.
• Strong project management, financial, and resource planning skills, with the ability to prioritize and delegate in a changing environment.
• Effective written, verbal, and presentation skills; able to lead, motivate, negotiate, and influence cross-functional teams.
• Proactive judgment, analytical problem-solving, adaptability, and familiarity with clinical development guidelines and project systems.

**Benefits and work setup**

The listing describes a remote role based in the United States.