Vendor Alliance Lead Associate Director

Key Accountabilities:

Operational Management / Deliverables

• Works within a matrix environment, the VCE is accountable for all operational aspects of 1 or more ERMTs  

• May oversee a team of Vendor Startup Managers (VSM) or Imaging Operation Managers (IOM) including assignment of trial level support, and as a point of escalation in addition to oversight responsibilities.  

• Supplier Service or Equipment expert for the assigned services within the ERMTs to drive value beyond cost from Novartis’ external supplier base  

• Supports the implementation of the agreed outsourcing program strategies  

• Responsible for supplier governance, management and issue management/escalation across global clinical operations locally and cross divisionally as required (e.g., Country, Novartis Institutes for BioMedical Research (NIBR), Sandoz).  

• Functions as a point of escalation for supplier issues which cannot be resolved at the individual Clinical Trial Teams level  

• Leverages knowledge, experience and understanding of service category(s) and suppliers to provide support to the operational management within the ERMT(s)  

• Leads business review meetings with vendors based on Key Performance Indicators (KPI), Key Quality Indicators (KQI) and multiple dashboards 

• Leads and/or supports internal cross-functional ERMT meetings  

• May lead team of VSMs or IOMs 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 

• Functions 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 

• Supports global and local vendor qualification if required 

• Supports VSMs or IOMs in collaboration with the SSU-teams 

Activities and Interfaces

• Optimizes a frontloaded and accelerated study start-up process with VSM/IOM and SSU teams  

• Vendor performance at aggregated above-study level. Collection and assessment of KPIs and KQIs  

• Provides risk-based governance and oversight for vendors, ensuring compliance with all regulatory and quality requirements  

• Consults for Service / Category specific expertise  

•  Supports standardization of service delivery  

• Local vendor management; provides expertise for qualifications and consulting for countries in their issue management activities  

• Near-time vendor management by using technological enablers UVP and portals/interfaces with vendors  

• Timely oversight, completion, and management of assigned supplier qualification and re-qualification requirements at global and country level  

• Accountable for quality and completeness of qualification and governance documentation in Vendor Partnerships and Governance (VPG) systems  

• Manages and maintain due diligence document templates and tools  

• Develops supplier management plans within ERMT(s) including appropriate governance structures 

• Contributes to process improvement and harmonization across divisions and functions to ensure compliance with all Novartis policies and procedures 

Compliance with Parexel Standards

• Complies with required training curriculum  

• Completes timesheets accurately as required  

• Submits expense reports as required  

• Updates CV as required  

• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs, and other applicable requirements 

Skills: 

• Very strong vendor management skills  

• Demonstrated strategic skills; organizational knowledge; advanced planning and project management skills, as well as an advanced understanding of business processes  

• Ability to influence without authority and independent ability to build highly functioning teams  

• Partnering skills across divisions with internal and external stakeholders  

• Strong negotiation, time management and conflict resolution skills  

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

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

• Excellent influencing and communication skills  

• Proficient in written and spoken English 

Knowledge and 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 

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

• Experience in User Acceptance testing  

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

• Experience or Expertise with Central Labs, Electronic Clinical Outcomes Assessment (eCOA), and Electronic Patient Reported Outcome (ePRO), Interactive Response Technology (IRT), Cardiac and Respiratory diagnostics, Patient Recruitment and Retention (PR&R), Imaging reading (global process ownership, business system owner, SOP management, global training on supplier related SOPs and processes)  

Education: 

• Bachelor's degree in science or business required  

• Master's or Doctorate degree in Science or Business preferred