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IRT Vendor Start-up Manager – FSP
ParexelIRT Vendor Start-up Manager at Parexel, providing expertise in vendor management for clinical trial operations. Collaborate on study specifications and ensure compliance and service excellence with vendors.
About the role
Key responsibilities & impact- Provide technical expertise for the category throughout start-up to close out
- Support implementation of defined category strategies and service standardization
- Ensure compliance through the life of the studies assigned
- Proactively assess risk and conclude contingency plans to de-risk study start-up
- Review of the IRT vendor and category related specific sections of the protocol
- Contribute to development of Study Specification Worksheet (SSW)
- Ensure all submission documents are provided by vendor to countries participating in a study
- Support for program overview by providing study demands to VCE
- Ensure changes to country and site plans are consistently shared with vendors and VCE
- Document issues identified with vendor oversight / performance
- Drive root cause analysis of supplier performance issues
- Collaborate across sponsor’s departments to provide data for vendor qualification efforts
- Review and approve invoices against activity
Requirements
What you’ll need- 3+ years working experience
- Very strong IRT vendor management skills
- Excellent knowledge of clinical operation processes and IRT vendor management
- Excellent knowledge of GxP and ICH regulations
- Expert knowledge of clinical trial design and mapping to supplier requirements
- Demonstrated root cause analysis, problem solving, and solution generation skills.
- Bachelor's degree in science or business required, with equivalent experience.
Benefits
Comp & perks- Health insurance
- Flexible working hours
- Professional development opportunities
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Clinical Operation ProcessesStudy Specification DevelopmentContingency PlanningVendor OversightProblem SolvingSolution Generation
Soft Skills
CollaborationCommunication
Certifications
Bachelor's Degree in Science or Business