Project Manager - REMS Team - Remote based in the US

Thermo Fisher Scientific • Morrisville, NC

2d • Remote

About The Position

The Project Manager serves as the project lead and primary sponsor contact, accountable for overall project delivery in terms of quality, time, and cost. The role leads a cross-functional project team to meet or exceed deliverables and establishes and communicates customer expectations. The position requires experience managing full-service clinical trials; REMS-specific experience is preferred, while 3–5 years of REMS experience is listed as required.

The Project Manager is responsible for project-level financial stewardship, including understanding the contract, aligning resources with the budget, managing out-of-scope activity, driving change-modification processes and negotiations, and keeping the team on schedule. The role also drives risk identification and issue resolution and ensures the team complies with organizational policies, SOPs, ICH-GCP, regulatory requirements, and project-specific requirements.

The role is remote-based in the US and follows a standard Monday–Friday schedule. Work may be performed in an office, laboratory, and/or clinical environment, with potential exposure to biological fluids and infectious organisms, as well as electrical office equipment. Personal protective equipment such as protective eyewear, garments, and gloves may be required.

Requirements

• 3–5 years of REMS experience.
• Bachelor’s degree or equivalent and relevant formal academic or vocational qualification.
• Previous experience providing knowledge, skills, and abilities comparable to 8+ years of experience.
• Technical and systems competency, including Microsoft Outlook, Word, Excel, PowerPoint, and organizational systems such as CTMS, Preclarus, and Clarity.
• Ability to delegate and effectively prioritize personal and project-team workloads in a frequently changing environment.
• Effective oral and written communication and presentation skills.
• Proactive, solutions-oriented, and adaptable to changing priorities and situations.
• Advanced therapeutic-area knowledge and knowledge of clinical development guidelines and directives.
• Strong understanding of project-management principles, including time, quality, cost, and financial acumen.
• Interpersonal and customer-service skills, including the ability to lead, motivate, and coordinate cross-functional project teams.
• Good judgment and decision-making skills, with the ability to apply critical, analytical, and strategic thinking to complex or ambiguous situations.
• Ability to negotiate, persuade, and influence others, including cross-cultural awareness.
• Ability to work in environments where there may be exposure to biological fluids and infectious organisms and to use required personal protective equipment.

Nice To Haves

• Experience managing full-service clinical trials.
• REMS-specific experience.

Responsibilities

• Serve as the primary project-level contact between the sponsor and the organization.
• Ensure internal and external escalation pathways and communication rules are followed.
• When required by project scope, establish clear responsibilities and communication pathways for secondary project leads, including regional, vendor, or delivery-subset leads.
• Account for overall cross-functional project delivery across time, cost, and quality.
• Provide project-level financial stewardship by understanding the contract, aligning resources to budget, managing out-of-scope activity, driving change-modification processes and negotiations, and ensuring team execution to timelines.
• Establish, communicate, and manage customer expectations to support optimal project delivery.
• Drive project-level risk identification and issue resolution using RBQM/RESOLVE.
• Ensure project team compliance with organizational policies, SOPs, ICH-GCP, regulatory requirements, and project-specific requirements.
• Lead and coordinate the cross-functional project team to meet or exceed deliverables.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior