Band

Level 5

Job Description Summary

The Vendor Alliance Lead (VAL) is responsible for the management of outsourced clinical activities and deliverables of one or more supported External Relationship Management Teams (ERMT).
• Working within a matrix environment, the VAL is accountable for all operational aspects of 1 or more ERMTs
• May manage a team of Vendor Startup Managers (VSM) including assignment of trial level support, and as a point of escalation in addition to people management responsibilities.
• Supplier Service or Equipment expert for the assigned services within the ERMTs to drive value beyond cost from Novartis’ external supplier base
• Supporting the implementation of the agreed outsourcing program strategies
• Responsible for supplier governance, management and issue management/escalation across global GCO and locally and cross-divisionally as required (e.g. Country, NIBR, etc.).
• Function as a point of escalation for supplier issues which cannot be resolved at the individual Clinical Trial Teams level
• Leverage knowledge, experience and understanding of service category(s) and suppliers to provide support to the operational management within the ERMT(s)
• Lead supplier due diligence activities with ERMT

Job Description

Major accountabilities:

• Lead business review meetings with vendors based on KPI, KQI and UVP dashboards

• Lead and/or support internal cross-functional ERMT meetings

• May lead team of Vendor Startup Managers (VSM) to support supplier startup activities

• Manages escalated global vendor issues, or selected country vendor issues

• Identifies systemic patterns, driving root cause analysis and sustainably and effectively addresses pain points

• Using technological enablers to drive automated and systematic near-time issue resolution

• Function as category expert providing expertise and training to stakeholders

• Ensures compliance with all required SOPs and business guidance documents

• Provides Health Authority inspection support

• CAPA management from audit & inspections

• Drives value through process improvement and innovation within category

• Proactive risk management within category

• Supporting global and local vendor qualification if required

• Supports Vendor Start-up Managers (VSM) in collaboration with the SSU-teams

Key performance indicators:

• ERMT(s) meeting business objectives

• Robust processes to capture and measure the resolution, escalation, and communication of supplier quality/performance issues

• Highly integrated and seen as supplier experts within ERMTs, CTTs and Franchise teams

• No deviations to Novartis specifications and Standard Operating Procedures; Supplier due diligence activities (qualifications and re-qualifications) are completed in a timely manner to minimize any delays to study startup timelines and non-compliance

• Contribute to continuous improvements/enhancements to benefit business community

• Complete and accurate documentation to facilitate successful internal and external audit / inspections

• Timely oversight, completion, and management of assigned supplier qualification and re-qualification requirements

• Accountable for quality and completeness of qualification and governance documentation in VPG systems including ERMT meeting minutes

• Manage and maintain due diligence document templates and tools

Minimum Requirements:
Education:

• Advanced degree in science or business with equivalent experience

Work Experience:

• 5+ years working experience and excellent 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

• Thorough and technical understanding of Novartis specifications for supplier provided services

• Demonstrated leadership with supplier relationship management and/or expert knowledge of specific service areas

• Demonstrated partnering across divisions with internal and external stakeholders

• Demonstrated root cause analysis, problem solving, and solution generation skills

• History of successfully working in a cross-functional global team and proven ability to function in matrix structure organization

• Leadership to deliver projects according to required and deliverables

• Excellent influencing and communication skills

• Experience or expertise in one or more of Vendor Management Role accountabilities (e.g. global process ownership, business system owner, SOP & FMR management, global training on supplier related SOPs and processes)

Skills:

• Budget Management.

• Clinical Trials.

• Negotiation Skills.

• People Management.

• Process Improvement.

• Project Management.

• Project Planning.

• Vendor Management.

Languages :

• Fluent English, oral and written

Skills Desired

Budget Management, Clinical Trials, Negotiation Skills, People Management, Process Improvement, Project Planning, Vendor Management, Waterfall Model