[Remote] Project Lead/Project Manager - FSP

Note: The job is a remote job and is open to candidates in USA. Thermo Fisher Scientific is a global team that values passion, innovation, and scientific excellence. The Project Lead/Project Manager is responsible for the overall delivery of clinical trials, leading cross-functional teams, ensuring regulatory compliance, and managing project timelines and budgets.ResponsibilitiesResponsible for the delivery of the cross-functional project (time, cost, quality)​ by working closely with Global trial and functional leadsEnsures 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 timelinesEstablishes, communicates and manages customer expectations to achieve optimal delivery during the project​Drives Risk Identification and Issue Resolution at project levelEnsures project team compliance with organization policies, SOPs, ICH- GCP, regulatory and project specific requirements​Responsible for vendor management, where requiredAbility to delegate and effectively prioritize own and workload of project team members in a frequently changing environmentEffective oral and written communication and presentation skillsProactive, solutions oriented and adaptable to changing priorities and situationsAdvanced therapeutic area knowledge and clinical development guidelines and directivesSound interpersonal and customer service skills, including the ability to lead, motivate and coordinate cross-functional project teamsAbility to negotiate, persuade and influence others, including a cross-cultural awarenessSkillsB.A. or B. Sc. in a scientific discipline6 + years in clinical operations management, managing clinical trials per quality, timeline, and budget expectations, preferably with a Sponsor company and a CRORelated scientific and clinical expertise and exceptional project-management, risk-assessment, contingency-planning, and communication skillsExtensive knowledge of clinical development related to one or more trial phases (I, II, III), as well as cross-functional drug developmentExpertise in Good Clinical Practices (GCP), International Council for Harmonization (ICH) guidelines and regulatory requirements for clinical developmentAbility to establish and execute operational plansTechnical 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 systemsAbility to delegate and effectively prioritize own and workload of project team members in a frequently changing environmentEffective oral and written communication and presentation skillsProactive, solutions oriented and adaptable to changing priorities and situationsAn advanced degree in a related fieldInvestigator site and/or monitoring experienceFunctional Service Provider (FSP) experienceCompany OverviewThermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services. It was founded in 1956, and is headquartered in Waltham, Massachusetts, USA, with a workforce of 10001+ employees. Its website is https://www.thermofisher.com.Company H1B SponsorshipThermo Fisher Scientific has a track record of offering H1B sponsorships, with 33 in 2026, 272 in 2025, 224 in 2024, 233 in 2023, 342 in 2022, 315 in 2021, 227 in 2020. Please note that this does not guarantee sponsorship for this specific role.