Vendor Category Expert - Serbia - FSP
Serbia, Remote ID de la oferta R0000024654 Categoría Clinical Trialssobre este trabajo
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.
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 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
Contributes to process improvement and harmonization across divisions and functions to ensure compliance with all Novartis policies and procedures
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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