Project Lead/Project Manager - FSP

Thermo Fisher Scientific • Morrisville, NC

23h • Onsite

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, cost) on behalf of the organization. Additionally, the Project Manager establishes and communicates customer expectations to the project team and ensures that escalation pathways are adhered to internally and externally. The role involves leading the cross functional project team to meet or exceed deliverables. As part of the Study Management Team (SMT), is accountable for the implementation and execution of study plans to support successful clinical trial delivery.

Requirements

• B.A. or B. Sc. in a scientific discipline.
• 6 + years in clinical operations management, managing clinical trials per quality, timeline, and budget expectations, preferably with a Sponsor company and a CRO.
• Related scientific and clinical expertise and 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), as well as 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, such as computer skills, to include effective use of systems and applications such as Microsoft Outlook, Word, Excel and PowerPoint, as well as organization systems.
• Ability to delegate and effectively prioritize own and workload of project team members in a frequently changing environment
• Effective oral and written communication and presentation skills
• Proactive, solutions oriented and adaptable to changing priorities and situations
• Sound interpersonal and customer service skills, including the ability to lead, motivate and coordinate cross-functional project teams
• Ability to negotiate, persuade and influence others, including a cross-cultural awareness

Nice To Haves

• An advanced degree in a related field.
• Investigator site and/or monitoring experience.
• Functional Service Provider (FSP) experience.

Responsibilities

• Responsible for the delivery of the cross-functional project (time, cost, quality) by working closely with Global trial and functional leads.
• Ensures escalation pathways adhered to internally and externally (Rules of Engagement – communication pathways).
• On projects where the scope requires, ensures clear delineation in responsibilities and communication pathways for secondary project leads (such as lead in a specific region, lead for a specific vendor(s) or subset of delivery).
• Ensures financial stewardship at a trial level by demonstrating an intimate understanding of the contract, resource alignment to budget, management of Out-of-Scope activity, drive the Con Mod process/negotiations and team execution to timelines.
• Establishes, communicates and manages customer expectations to achieve optimal delivery during the project
• Drives Risk Identification and Issue Resolution at project level
• Ensures project team compliance with organization policies, SOPs, ICH- GCP, regulatory and project specific requirements.
• Responsible for vendor management, where required

Benefits

• When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

What This Job Offers

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