Vendor Start-up Manager
4 weeks ago
Vendor Start-up Manager (VSM) is responsible for providing expertise in support of outsourced clinical trial activities during study startup. 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.
About the RoleResponsibilities:
- Work in close collaboration with the Vendor Program Manager (VPM) and CRO during study startup phase to optimize a front loaded and timely study start-up process.
- Contribute to the development of Study Specification Worksheet (SSW) to facilitate bid process and selection of Vendors.
- Review vendor proposal/budget in collaboration with procurement (and vendor). If required, support contract negotiations.
- Ensure changes to protocol or study designs are consistently shared with vendors and incorporated into supplier budgets, timelines, and specifications. Support amendment of vendor contracts with Procurement team.
- Vendor service excellence at study level, ensuring vendors meet quality and service level standards in their service delivery for the trial.
- Pro-actively create and maintain vendor related risk maps with contingency plan for documentation.
- Document issues identified with vendor oversight/performance and implement and monitor corrective actions. Escalate issue if required to the Vendor Category Expert (VCE).
Requirements:
- Bachelor degree in science and/or business. Advanced degree preferred.
- Demonstrated experience and knowledge of the clinical operation processes and vendor management.
- Excellent knowledge of GxP and ICH regulations.
- Expert knowledge of clinical trial design and mapping to supplier requirements.
- Demonstrated leadership with supplier relationship management and/or specific service areas.
- Experience partnering across divisions with internal and external stakeholders.
- Demonstrated root cause analysis, problem solving, and solution generation skills.
- Knowledge of key deliverables that impact green light milestones and vendor readiness.
- Experience in outsourcing, contracting, sourcing of clinical services with Vendor/CROs (RFP, RFQ, contracting).
Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us
Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Division: Development
Business Unit: Innovative Medicines
Location: Ireland
Site: Dublin (Novartis Corporate Center (NOCC))
Company / Legal Entity: IE02 (FCRS = IE002) Novartis Ireland Ltd
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