Vendor Start up Manager – eCOA

This is a fully remote position, open to applicants in United Kingdom, +6 more countries.

📋 Description

• Review specific protocol requirements for vendors and categories, integrating supplier expertise into the final study specifications.

• Assist in the creation of Study Specification Worksheets (SSWs) for the selection and bidding of vendors.

• Collaborate with Procurement and vendors to assess proposals and quotations, facilitating contract negotiations.

• Evaluate and validate vendor budgets in relation to project scope and quotations.

• Organize vendor kick-off meetings and guide governance discussions throughout the study's lifecycle.

• Coordinate the collection and submission of vendor documentation for regulatory authority approvals.

• Lead User Acceptance Testing (UAT) for systems like eCOA and IRT.

• Communicate amendments to protocols and changes in study design to vendors, updating budgets, timelines, and service agreements accordingly.

• Drive study start-up activities to ensure timely deployment of vendor databases and operational readiness.

• Monitor vendor performance to ensure compliance with quality, timeline, and service standards.

• Identify potential vendor risks and formulate mitigation and contingency strategies.

• Oversee performance issues, applying corrective measures and escalating concerns as necessary.

• Conduct root-cause analyses and track supplier performance trends.

• Contribute to the development of vendor management processes, templates, tools, and best practices.

⛳️ Requirements

• Advanced degree in a scientific, life sciences, or business-related field, or comparable industry experience.

• Proficient in both written and spoken English.

• Over 3 years of experience in clinical operations, with a strong focus on vendor management and oversight.

• Comprehensive understanding of GxP, ICH-GCP, and relevant regulatory requirements.

• Extensive knowledge of clinical trial design and the ability to translate study requirements into deliverables from vendors.

• Strong grasp of clinical services provided by suppliers and their operational specifications.

• Proven experience in managing vendor relationships and collaborating with external service providers.

• Demonstrated capability to establish effective partnerships with both internal and external stakeholders.

• Experience in leading or assisting with User Acceptance Testing (UAT), particularly for eCOA and IRT platforms.

• Familiarity with study start-up milestones, vendor readiness activities, and critical path deliverables.

• Experience in supporting outsourcing, vendor selection, contracting, and procurement processes, including RFPs and RFQs.

• Expertise in one or more clinical vendor categories, such as Central Laboratories, eCOA/ePRO, IRT, Imaging, Cardiac and Respiratory Diagnostics, or Patient Recruitment and Retention (PR&R).

• Legal authorization to work in the country where the position is based.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.