REMS Project Manager: Clinical Trials Lead

NCBioImpact; North Carolina; A distancia; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

Thermo Fisher Scientific is seeking a Project Manager to lead full-service clinical trial delivery with REMS experience preferred. You will act as the project lead and sponsor contact, guiding cross-functional teams to meet scope, quality, and timelines, while ensuring adherence to contracts and budgets.

The role emphasizes strong communication, risk management, and regulatory compliance within a fast-paced, office-based setting. Bachelor’s degree required and 3–5 years REMS experience expected.

Formación

• 3-5 years REMS experience required.
• Bachelor's degree or equivalent and relevant formal academic/ vocational qualification.
• Experience comparable to 8+ years in related roles.

Responsabilidades

• Serve as the project-level sponsor contact for the sponsor.
• Ensure escalation pathways are followed and manage communication.
• Define responsibilities and communication for secondary project leads when needed.
• Accountable for overall delivery: time, cost, quality.
• Oversee budgeting, contract understanding, and cost management at project level.
• Manage customer expectations to achieve optimal delivery.
• Lead risk and issue management (RBQM/RESOLVE).
• Ensure compliance with SOPs, ICH-GCP, regulatory and project requirements.

Conocimientos

REMS experience

Project management

Financial acumen

Microsoft Office

CTMS

Cross-functional leadership

Communication skills

Analytical thinking

Educación

Bachelor's degree or equivalent

Herramientas

CTMS

Preclarus

Clarity

Microsoft Office

Descripción del empleo

Thermo Fisher Scientific is seeking a Project Manager to lead full-service clinical trial delivery with REMS experience preferred. You will act as the project lead and sponsor contact, guiding cross-functional teams to meet scope, quality, and timelines, while ensuring adherence to contracts and budgets.

The role emphasizes strong communication, risk management, and regulatory compliance within a fast-paced, office-based setting. Bachelor’s degree required and 3–5 years REMS experience expected.