IRT Vendor Start-up Manager – FSP

ManagerManagerFull TimeRemoteSeniorTeam 10,001+Since 1983H1B SponsorCompany SiteLinkedIn

Location

United Kingdom

Posted

1 day ago

Salary

0

Seniority

Senior

Bachelor Degree3 yrs expEnglish

Job Description

IRT Vendor Start-up Manager – FSP

Parexel

• 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

Job Requirements

  • 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

  • Health insurance
  • Flexible working hours
  • Professional development opportunities

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