Vendor Category Expert - UK - FSP

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 :

Operational Management / Deliverables

Works within a matrix environment, the VCE is accountable for all operational aspects of 1 or more ERMTs. (Develop supplier management plans within ERMT(s) including appropriate governance structures).

Oversee a team of Vendor Start-up Managers (VSM) including assignment of trial level support (including supplier start-up activities), and as a point of escalation in addition to oversight responsibilities.

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

Supplier Service or Equipment expert for the assigned services within the ERMTs to drive value beyond cost from the 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.

Manage escalated global, or selected country vendor issues and provide timely oversight of qualification requirements.

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 as well as proactive risk management.

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 abilities.

Proficient in written and spoken English.

Knowledge & 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.