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Vendor Category Expert - FSP

Romania, Remote Job ID R0000023064 Category Clinical Trials
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About this Role

Job Purpose:

Reporting to the Head Vendor Alliances, the Vendor Category Expert (VCE) is responsible for the management of outsourced clinical activities and deliverables of one or more External Relationship Management Teams (ERMT).

Key Accountabilities:

Accountability

  • 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) including assignment of trial level support, and as a point of escalation in addition to oversight responsibilities.

  • 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 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 VSM in collaboration with the SSU-teams

Activities and Interfaces

  • Optimizes a frontloaded and accelerated study start-up process with VSM 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

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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