Project Manager – FSP Trial Lead

🔥 15 hours ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

👷‍♀️ Project Manager

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Serve as Project Lead and primary sponsor contact • Accountable for overall project delivery, including quality, time, and cost • Establish and communicate customer expectations to the project team • Ensure internal and external escalation pathways are followed • Lead cross-functional project teams to meet or exceed deliverables • Implement and execute study plans supporting successful clinical trial delivery • Work closely with Global Trial and functional leads • Define responsibilities and communication pathways for secondary project leads when required • Ensure financial stewardship at trial level, including contract understanding, resource alignment, out-of-scope activity management, Con Mod negotiations, and timeline execution • Drive project-level risk identification and issue resolution • Ensure compliance with organization policies, SOPs, ICH-GCP, regulatory, and project-specific requirements • Manage vendors where required • Delegate and prioritize the workload of project team members

🎯 Requirements

• B.A. or B. Sc. in a scientific discipline • Previous experience comparable to 8+ years, including 2+ years of project/trial management • Related scientific and clinical expertise • Exceptional project-management, risk-assessment, contingency-planning, and communication skills • Extensive knowledge of clinical development related to one or more trial phases (I, II, III) • Knowledge of cross-functional drug development • Expertise in Good Clinical Practices (GCP), International Council for Harmonization (ICH) guidelines, and regulatory requirements for clinical development • Ability to establish and execute operational plans • Technical and systems competency, including Microsoft Outlook, Word, Excel, PowerPoint, and organization systems • Ability to delegate and prioritize workload in a frequently changing environment • Effective oral, written communication, and presentation skills • Proactive, solutions-oriented, and adaptable to changing priorities and situations • Advanced therapeutic area knowledge and clinical development guidelines and directives • Sound interpersonal and customer service skills, including ability to lead, motivate, and coordinate cross-functional project teams • Ability to negotiate, persuade, and influence others, including cross-cultural awareness • Prior neurology therapeutic experience required • Ability to travel domestically and internationally

🏖️ Benefits

• Fully remote work arrangement