FSP Clinical Supplies Project Manager

🔥 5 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷‍♀️ Project Manager

👻 Ghost score 15%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Serve as the single point of contact for the study team and Clinical Supply Center • Manage logistical activities from draft concept protocol initiation through product delivery to the final depot • Translate study protocols into operational demand and assess logistical feasibility • Define logistics operational strategies covering supply, distribution, and randomization • Set up and follow up clinical supply activities for projects or groups of studies • Align stakeholders, GMP operations, and clinical operations to deliver vaccines and ancillaries on time, at the required quality, and within budget • Interface between Clinical Supply Center and Clinical Study Team, including study delivery, local delivery, labeling, packaging, depot, distribution, and quality partners • Provide input into study protocols and related documents, logistic instructions, requirements, due dates, and supply issues • Establish operational feasibility and escalate feasibility issues • Report planned studies and new demand to the planning team for capacity assessment • Define operational setup, workflows, strategies, labeling, warehousing, distribution, schedules, and budgets • Own supply chain processes and documents and ensure study activities are operationally set up and conducted as agreed • Manage collaboration with worldwide depots according to local country requirements • Ensure timely vaccine resupply based on recruitment strategies and changing study and country needs • Ensure study milestones are met by Clinical Supply Operations • Review and renegotiate study timings and due dates • Track study KPIs, identify trends, and ensure problems are addressed • Act as Subject Matter Expert for one or more team processes and standardize ways of working • Develop and maintain SOPs, WIKI content, guidance, and training materials • Maintain inspection readiness and document relevant communications and strategic decisions in eTMF/Veeva

🎯 Requirements

• Bachelor's Degree required; no prior experience required in project management or coordination • Preferred fields of study: Chemistry, Biology, Engineering, Business, or related discipline • Additional certifications in Project Management are valued but not required • Strong proficiency in Microsoft Office Suite, particularly Excel, PowerPoint, and Project • Excellent organizational and time management skills with ability to handle multiple projects simultaneously • Outstanding written and verbal communication skills • Detail-oriented with strong documentation and process management capabilities • Experience with quality systems and GMP compliance preferred • Ability to work independently while collaborating effectively with cross-functional teams • Strong analytical and problem-solving skills • Proficiency in English required; additional languages may be needed based on location • Experience with project management software and tools • Ability to identify and mitigate risks while maintaining project timelines • Strong customer service orientation with excellent interpersonal skills • Flexibility to adapt to changing priorities and deadlines • Understanding of relevant industry regulations and standards • Experience in pharmaceutical, healthcare, or scientific industries preferred

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