IRT Vendor Start-up Manager – UK or Ireland

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• The Vendor Start-up Manager (VSM) will deliver technical expertise for the category throughout the entire process from start-up to closure, collaborating closely with the VCE (Vendor Category Expert) and indirectly with the Clinical Trial Team.

• The VSM facilitates seamless and expedited vendor service delivery during the trial start-up phase while supporting the execution of established category strategies and service standardization, ensuring compliance throughout the duration of assigned studies.

• This position actively evaluates risks and formulates contingency plans to mitigate challenges during the study start-up phase and beyond.

• Reviews the IRT vendor and specific sections of the protocol related to the category, ensuring that IRT vendor expertise is utilized when refining specifications for the Final Protocol.

• Contributes to the creation of the Study Specification Worksheet (SSW) to streamline the bidding process and selection of IRT Vendors.

• Collaborates with procurement and vendors for quote/proposal reviews.

• Provides support for contract negotiations as needed.

• Conducts a review of vendor budgets based on final quotes.

• Responsible for vendor cost control, budget analysis, invoice reconciliation, and purchase order closure.

• Ensures that all submission documents required by participating countries are provided by the vendor.

• Assists with vendor contract amendments alongside the Procurement team.

• Aims to optimize a frontloaded and timely study start-up process to ensure site readiness.

• Guarantees IRT Vendor service excellence at the study level, ensuring that vendors meet the quality and service level standards expected in their service delivery for the trial.

• Acts as the escalation point for managing vendor-related queries.

• Proactively develops and maintains vendor-related risk maps along with contingency plans for documentation.

• Follows up with countries and Hubs regarding their vendor-related risks and issues.

• Records issues identified during vendor oversight or performance using the sponsor’s internal tool, implementing and monitoring corrective actions as necessary.

• Drives root cause analysis of supplier performance issues while identifying trends.

⛳️ Requirements

• A minimum of 3 years of working experience with comprehensive knowledge of clinical operation processes and IRT vendor management.

• Strong understanding of GxP and ICH regulations.

• Expert knowledge of clinical trial design and its alignment with supplier requirements.

• Proven leadership skills in supplier relationship management and/or in-depth knowledge of specific service areas.

• Demonstrated ability to partner across divisions with both internal and external stakeholders.

• Skilled in root cause analysis, problem-solving, and generating solutions.

• Experience in IRT User Acceptance Testing.

• Awareness of key deliverables that affect green light milestones and vendor readiness.

• Experience in outsourcing, contracting, and sourcing clinical services with vendors/CROs.

• A Bachelor's degree in science or business is required, or equivalent experience is acceptable.

🏝️ Benefits

• Health insurance

• Flexible work arrangements

• Professional development opportunities