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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.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in IRT vendor management and clinical operation processes, ensuring compliance with GxP and ICH regulations while effectively managing study specifications and vendor performance.
Highest-signal resume keywords
IRT Vendor ManagementClinical Trial DesignGxP RegulationsICH RegulationsRoot Cause Analysis
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Operation ProcessesStudy Specification DevelopmentContingency PlanningVendor OversightProblem SolvingSolution Generation
Soft Skills
CollaborationCommunication
Certifications & Qualifications
Bachelor's Degree in Science or Business
Industry Keywords
Clinical TrialsVendor QualificationStudy DemandsSubmission Documents
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