IRT Vendor Start Up Manager

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

📋 Description

• Review specific sections related to vendors and categories in the protocol, ensuring vendor expertise is utilized for refining specifications toward the Final Protocol.

• Contribute to the development of the Study Specification Worksheet (SSW) to aid in the bidding process and vendor selection.

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

• Provide support for contract negotiations as needed.

• Review vendor budgets against final quotes.

• Responsible for vendor cost control, budget assessment, invoice reconciliation, and purchase order close-out.

• Assist in program oversight by supplying study demands to the Vendor Category Expert (VCE).

• Ensure that all necessary submission documents are obtained from vendors for countries involved in a study.

• Work closely with trial and monitoring teams to comprehend site requirements for study participation.

• Ensure that changes to country and site plans are consistently communicated to vendors and the VCE for start-up, resupply, and close-out.

• Assist in amending vendor contracts in collaboration with the Procurement team.

• Optimize a frontloaded and prompt study start-up process to facilitate timely site readiness.

• Ensure vendor service excellence at the study level, guaranteeing that vendors meet quality and service level standards in their trial delivery.

• Act as an escalation point for managing vendor-related inquiries.

• Proactively create and maintain vendor-related risk maps with contingency plans for documentation.

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

• Document vendor oversight and performance issues using the sponsor’s internal tool, implementing and monitoring corrective actions.

• Escalate issues to the Vendor Category Expert (VCE) when necessary.

• Drive root cause analysis of supplier performance issues and identify trends.

• Support the implementation of standards, templates, tools, and processes for vendors in defined categories in collaboration with the VCE.

• Utilize the Unified Vendor Portal (UVP) for managing vendor service delivery.

• Assist practice leaders in improvement projects and learning initiatives.

• Collaborate across the sponsor’s departments to provide data for vendor qualification efforts.

• Review and approve invoices based on activity.

• Partner with vendors to develop training materials for sites and monitors, providing support for training as needed.

⛳️ Requirements

• Advanced degree in science or business, or equivalent experience.

• Over 3 years of relevant work experience and a strong understanding of clinical operation processes and vendor management.

• Experience in designing Interactive Response Technology (IRT) systems.

• Familiarity with User Acceptance Testing (UAT).

• In-depth knowledge of GxP and ICH regulations.

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

• Experience in managing Patient Recruitment and Retention vendors/services.

• Proven leadership in supplier relationship management and/or expert knowledge in specific service areas.

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

• Proven skills in root cause analysis, problem solving, and generating solutions.

• Knowledge of key deliverables that impact green light milestones and vendor readiness.

• Experience in outsourcing, contracting, and sourcing clinical services with IRT Vendors.

• Specific category expertise is desirable, particularly in global equipment supply and/or radiation, though it is not mandatory.

🏝️ Benefits

• Competitive salary.

• Comprehensive benefits package.

• Medical care plan covering Health, Dental, and Vision.

• Life Assurance.

• Positive work environment.

• Culture of teamwork and collaboration.

• Supportive colleagues who motivate and tackle challenges together.

• Access to innovative technology.

• Excellent training opportunities.