About this role

Ensures vendors are fully aligned, validated, and ready to deliver
Provides technical expertise during study startup to the TVM Trial Vendor Manager
Enables flawless and accelerated vendor service delivery
Proactively assesses risk and concludes contingency plans to de-risk study startup
Reviews vendor-related specific sections of the protocol
Contributes to development of Study Specification Worksheet (SSW)
Coordinates vendor kick-off meeting and other vendor-specific meetings
Collects HA submission documents from vendor
Performs robust User Acceptance Testing (UAT) for eCOA
Ensures changes to protocol or study designs are shared with vendors
Promotes Vendor service excellence at the study level

Advanced degree in science or business with equivalent experience
Strong demonstrated experience in the eCOA industry (ideally a period of 5-7+ years working in eCOA)
Excellent knowledge of GxP and ICH regulations
Expert knowledge of clinical trial design and mapping to supplier requirements
Demonstrated leadership with supplier relationship management
Strong collaborative mindset and capability to liaise closely with key stakeholders
Demonstrated root cause analysis, problem solving, and solution generation skills
Experience in User Acceptance testing (eCOA)
Knowledge of key deliverables that impact green light milestones and vendor readiness

Vendor Start-Up Manager – eCOA, Translations

Key skills