Vendor Start-up Manager-eCOA/Translations

Novartis AG; City of Westminster; On-site; GBP 50,000 - 70,000; Full time

Job summary

A global healthcare leader is seeking a Vendor Startup Manager to provide technical expertise and manage vendor services during study startup. The ideal candidate will have over 5 years of experience in clinical operations and vendor management, along with a strong proficiency in User Acceptance Testing for eCOA and IRT systems. This position focuses on optimizing study startup processes and ensuring vendor alignment with project requirements.

Qualifications

• Over 5 years of experience in clinical operations and vendor management.
• Expertise in GxP, ICH regulations, and Novartis specifications.
• Technical proficiency in UAT for eCOA and IRT systems.

Responsibilities

• Review vendor-related protocol sections and specifications.
• Manage vendor budgets and ensure smooth integration.
• Conduct root cause analysis of supplier performance issues.

Skills

Clinical operations processes

Vendor management

Supplier requirements

User Acceptance Testing (UAT)

Strong interpersonal skills

Job description

Overview

The Vendor Startup Manager is responsible to provide technical expertise for a given category during study startup to the VPM Vendor Program Manager and indirectly to the study start-up team. The VSM enables a flawless and accelerated vendor service delivery at the trial start-up phase and supports implementation of defined category strategies and service standardization. This role proactively assesses risk and concludes contingency plans to de-risk study startup.

Responsibilities

• Review vendor-related protocol sections and refine specifications using vendor expertise.
• Contribute to study specification development, review quotes/proposals, and support contract negotiations and amendments.
• Manage eCOA and IRT vendors, ensuring robust User Acceptance Testing (UAT) and smooth integration into study plans.
• Oversee vendor budgets, kick-off meetings, and specific discussions to align vendors with study requirements.
• Collect submission documents and optimize study start-up processes, focusing on vendor database go-live timelines.
• Create vendor risk maps, document issues related to vendor performance, implement corrective actions, and escalate when necessary.
• Conduct root cause analysis of supplier performance issues, focusing on trends affecting eCOA and IRT vendors.
• Use vendor management platforms to monitor service delivery and collaborate on vendor qualification efforts.

Qualifications

• Over 5 years of experience and strong knowledge of clinical operations processes, vendor management, and supplier requirements.
• Expertise in GxP, ICH regulations, and Novartis specifications for supplier-provided services.
• Technical proficiency in User Acceptance Testing (UAT) for eCOA and IRT systems.
• Strong skills in vendor management, including outsourcing, contracting, and sourcing of clinical services.
• Proven ability to work in cross-functional teams, influence, negotiate, and solve problems effectively.
• Results-driven with a track record of completing projects on time and taking responsibility for decisions.
• Excellent interpersonal skills, with strong written and verbal communication and networking capabilities.
• Collaborative approach to sharing knowledge, fostering teamwork, and supporting site activation processes.