Project Manager - REMS Team - Remote based in the US

Thermo Fisher Scientific • Morrisville, NC

1d • Remote

About The Position

The Project Manager serves as the Project Lead and primary sponsor contact and is accountable for the overall delivery of the project—quality, time, and cost—on behalf of the organization. The role leads the cross-functional project team to meet or exceed deliverables, establishes and communicates customer expectations, and ensures internal and external escalation pathways are followed. Where project scope requires, the Project Manager ensures clear delineation of responsibilities and communication pathways for secondary project leads, such as regional leads or leads for particular vendors or delivery subsets.

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

The position requires experience managing full-service clinical trials, with REMS-specific experience preferred in the description; the education and experience requirements specify 3–5 years of REMS experience. Work is performed in an office/laboratory and/or clinical environment, with possible exposure to biological fluids and infectious organisms, as well as electrical office equipment. Personal protective equipment such as protective eyewear, garments, and gloves is required.

Requirements

• 3–5 years of REMS experience.
• Bachelor’s degree or equivalent and relevant formal academic or vocational qualification.
• Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 8+ years.
• Technical and systems competency, including effective use of 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 approach 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, and cost, and solid 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 critical, analytical, and strategic thinking to manage complex or ambiguous situations.
• Ability to negotiate, persuade, and influence others, including cross-cultural awareness.

Nice To Haves

• Experience managing full-service clinical trials.
• REMS-specific experience is listed as preferred, although the education and experience requirements also specify 3–5 years of REMS 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, clarify responsibilities and communication pathways for secondary project leads.
• Account for overall cross-functional project delivery in terms of 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 keeping team execution on schedule.
• Establish, communicate, and manage customer expectations to support optimal project delivery.
• Drive project-level risk identification and issue resolution.
• Ensure the project team complies 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