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 TeamsMay 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 baseSupports the implementation of the agreed outsourcing program strategiesResponsible for supplier governance, management and issue management/escalation across global clinical operations locally and cross divisionally as requiredFunctions as a point of escalation for supplier issues which cannot be resolved at the individual Clinical Trial Teams levelLeverages 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 dashboardsLeads and/or supports internal cross-functional ERMT meetingsMay lead team of VSMs or IOMs to support supplier startup activitiesManages escalated global vendor issues, or selected country vendor issuesIdentifies systemic patterns, driving root cause analysis and sustainably and effectively addresses pain pointsUsing technological enablers to drive automated and systematic near-time issue resolutionFunctions as category expert providing expertise and training to stakeholdersEnsures compliance with all required SOPs and business guidance documentsProvides Health Authority inspection supportCAPA management from audit & inspectionsDrives value through process improvement and innovation within categoryProactive risk management within categorySupports global and local vendor qualification if requiredSupports 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 teamsVendor performance at aggregated above-study level. Collection and assessment of KPIs and KQIsProvides risk-based governance and oversight for vendors, ensuring compliance with all regulatory and quality requirementsConsults for Service / Category specific expertise Supports standardization of service deliveryLocal vendor management; provides expertise for qualifications and consulting for countries in their issue management activitiesNear-time vendor management by using technological enablers UVP and portals/interfaces with vendorsTimely oversight, completion, and management of assigned supplier qualification and re-qualification requirements at global and country levelAccountable for quality and completeness of qualification and governance documentation in Vendor Partnerships and Governance (VPG) systemsManages and maintain due diligence document templates and toolsDevelops supplier management plans within ERMT(s) including appropriate governance structuresContributes 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 curriculumCompletes timesheets accurately as requiredSubmits expense reports as requiredUpdates CV as requiredMaintains a working knowledge of and complies with Parexel processes, ICH-GCPs, and other applicable requirements

Skills:

Very strong vendor management skillsDemonstrated strategic skills; organizational knowledge; advanced planning and project management skills, as well as an advanced understanding of business processesAbility to influence without authority and independent ability to build highly functioning teamsPartnering skills across divisions with internal and external stakeholdersStrong negotiation, time management and conflict resolution skillsDemonstrated leadership with supplier relationship management and/or expert knowledge of specific service areasDemonstrated root cause analysis, problem solving, and solution generation skillsExcellent influencing and communication skillsProficient in written and spoken English

Knowledge and Experience:

5+ years working experience and excellent knowledge of the clinical operation processes and vendor managementExcellent knowledge of GxP and ICH regulationsExpert knowledge of clinical trial design and mapping to supplier requirementsHistory of successfully working in a cross-functional global team and proven ability to function in matrix structure organizationExperience in User Acceptance testingKnowledge of key deliverables that impact green light milestones and vendor readinessExperience 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 requiredMaster's or Doctorate degree in Science or Business preferred

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EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.