
Vendor Management Specialist
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: North Carolina • United States
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Tech Stack
About the role
- 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 Biogen 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 Biogen 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
Requirements
- 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)
Benefits
- 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 rime off in accordance with company policy
- Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical operations managementclinical study managementvendor managementrisk assessmentcontingency planningproject managementGood Clinical Practices (GCP)International Council for Harmonization (ICH) guidelinesregulatory requirementsstudy specification creation
Soft Skills
communication skillscross-functional collaborationproblem solvingoversightperformance measurementissue trackingvendor relationship managementmeeting facilitationtransparencyteam management