
10,000+ employees
Founded 1956
🧬 Biotechnology
💊 Pharmaceuticals
🔬 Science
Biotechnology • Pharmaceuticals • Science
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.
🕒 June 12
🌲 North Carolina – Remote
⏰ Full Time
🟢 Junior
🟡 Mid-level
🛒 Procurement
🚫👨🎓 No degree required
🦅 H1B Visa Sponsor
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10,000+ employees
Founded 1956
🧬 Biotechnology
💊 Pharmaceuticals
🔬 Science
Biotechnology • Pharmaceuticals • Science
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.
• Manage third-party study vendors including study specification creation, collection, and finalization in conjunction with the relevant functional SMEs. • Responsible for the day-to-day management and oversight of third-party vendors at the study-level. • Responsible for keeping SMT updated regarding progress, issues tracking • Ensure study level contracted timelines and deliverables are clear and managed in the context of the vendor. • Proactively identify, elevate/escalate vendor issues that arise during study conduct to bring to resolution. • Manage and measure performance of the vendor on assigned study • Work with vendor to align KPI study delivery, management and measurement of vendor performance, escalating. • Demonstrate appropriate oversight of vendors through regular, well-structured meetings with vendors (including agendas and minutes) • Work with FSP Oversight Manager, Procurement to define project study specs and develop the Vendor Oversight Plan. • SVS will drive development of specific study level vendor management plans • Develops required study specific vendor materials • Support the coordination of vendor performance management meetings to a study level. • Provide accurate and up-to-date study level vendor information in relevant technology systems • Driving the cross-functional collaboration and problem solving to ensure study level vendor risk identification and mitigation. • Work closely with functional quality representatives (FQRs) to ensure vendor’s project deliverables meet quality standards. • Ensures vendor’s compliance with relevant Sponsor policies and procedures. • Facilitate effective communication and collaboration between SMT and vendor. • Ensures deliverable transparency from vendor to enable ease of invoice review and responsible for alerting Clinical Trial Lead CTL to invoice anomalies or inconsistencies
• High School diploma or equivalency (bachelor's degree preferred) • 2 + years in clinical operations management, managing clinical studies per quality, timeline, and budget expectations, with a Sponsor company or a CRO. • Exceptional project-management, risk-assessment, contingency-planning, and communication skills and strong cross functional collaboration. • Knowledge of clinical study management preferably related to one or more study phases (I, II, III) • Strong understanding and practical application of Good Clinical Practices (GCP), International Council for Harmonization (ICH) guidelines and regulatory requirements for clinical development • Demonstrated ability to establish and execute vendor plans according to study needs. • Clinical Study Management experience working with third party vendors (preferred)
• A choice of national medical and dental plans, and a national vision plan • A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Accounts (HSAs) or Health Savings Account (HSA) • Tax-advantaged savings and spending accounts and commuter benefits • Employee assistance programs • At least 120 hours paid time off (PTO). • 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, short- and long-term disability, and volunteer time off in accordance with company policy. • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
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