Parexel FSP is seeking a Vendor Alliance Lead Associate Director. This is a remote role in the United States.

Key Accountabilities:

Operational Management / Deliverables

• Works within a matrix environment, the VAL, Vendor Alliance Lead is accountable for all operational aspects of 1 or more ERMTs, External Relationship Management Teams
• 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 Sponsor's 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
• 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 Sponsor 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

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