Description

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.Key Accountabilities: Operational Management / Deliverables <ul><li>Works within a matrix environment, the VCE is accountable for all operational aspects of 1 or more ERMTs </li></ul><ul><li>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. </li></ul><ul><li>Supplier Service or Equipment expert for the assigned services within the ERMTs to drive value beyond cost from Novartis’ external supplier base </li></ul><ul><li>Supports the implementation of the agreed outsourcing program strategies </li></ul><ul><li>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). </li></ul><ul><li>Functions as a point of escalation for supplier issues which cannot be resolved at the individual Clinical Trial Teams level </li></ul><ul><li>Leverages knowledge, experience and understanding of service category(s) and suppliers to provide support to the operational management within the ERMT(s) </li></ul><ul><li>Leads business review meetings with vendors based on Key Performance Indicators (KPI), Key Quality Indicators (KQI) and multiple dashboards </li></ul><ul><li>Leads and/or supports internal cross-functional ERMT meetings </li></ul><ul><li>May lead team of VSMs or IOMs to support supplier startup activities </li></ul><ul><li>Manages escalated global vendor issues, or selected country vendor issues </li></ul><ul><li>Identifies systemic patterns, driving root cause analysis and sustainably and effectively addresses pain points </li></ul><ul><li>Using technological enablers to drive automated and systematic near-time issue resolution </li></ul><ul><li>Functions as category expert providing expertise and training to stakeholders </li></ul><ul><li>Ensures compliance with all required SOPs and business guidance documents </li></ul><ul><li>Provides Health Authority inspection support </li></ul><ul><li>CAPA management from audit & inspections </li></ul><ul><li>Drives value through process improvement and innovation within category </li></ul><ul><li>Proactive risk management within category </li></ul><ul><li>Supports global and local vendor qualification if required </li></ul><ul><li>Supports VSMs or IOMs in collaboration with the SSU-teams </li></ul> Activities and Interfaces <ul><li>Optimizes a frontloaded and accelerated study start-up process with VSM/IOM and SSU teams </li></ul><ul><li>Vendor performance at aggregated above-study level. Collection and assessment of KPIs and KQIs </li></ul><ul><li>Provides risk-based governance and oversight for vendors, ensuring compliance with all regulatory and quality requirements </li></ul><ul><li>Consults for Service / Category specific expertise </li></ul><ul><li> Supports standardization of service delivery </li></ul><ul><li>Local vendor management; provides expertise for qualifications and consulting for countries in their issue management activities </li></ul><ul><li>Near-time vendor management by using technological enablers UVP and portals/interfaces with vendors </li></ul><ul><li>Timely oversight, completion, and management of assigned supplier qualification and re-qualification requirements at global and country level </li></ul><ul><li>Accountable for quality and completeness of qualification and governance documentation in Vendor Partnerships and Governance (VPG) systems </li></ul><ul><li>Manages and maintain due diligence document templates and tools </li></ul><ul><li>Develops supplier management plans within ERMT(s) including appropriate governance structures </li></ul><ul><li>Contributes to process improvement and harmonization across divisions and functions to ensure compliance with all Novartis policies and procedures </li></ul> Compliance with Parexel Standards <ul><li>Complies with required training curriculum </li></ul><ul><li>Completes timesheets accurately as required </li></ul><ul><li>Submits expense reports as required </li></ul><ul><li>Updates CV as required </li></ul><ul><li>Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs, and other applicable requirements </li></ul> Skills: <ul><li>Very strong vendor management skills </li></ul><ul><li>Demonstrated strategic skills; organizational knowledge; advanced planning and project management skills, as well as an advanced understanding of business processes </li></ul><ul><li>Ability to influence without authority and independent ability to build highly functioning teams </li></ul><ul><li>Partnering skills across divisions with internal and external stakeholders </li></ul><ul><li>Strong negotiation, time management and conflict resolution skills </li></ul><ul><li>Demonstrated leadership with supplier relationship management and/or expert knowledge of specific service areas </li></ul><ul><li>Demonstrated root cause analysis, problem solving, and solution generation skills </li></ul><ul><li>Excellent influencing and communication skills </li></ul><ul><li>Proficient in written and spoken English </li></ul> Knowledge and Experience: <ul><li>5+ years working experience and excellent knowledge of the clinical operation processes and vendor management </li></ul><ul><li>Excellent knowledge of GxP and ICH regulations </li></ul><ul><li>Expert knowledge of clinical trial design and mapping to supplier requirements </li></ul><ul><li>History of successfully working in a cross-functional global team and proven ability to function in matrix structure organization </li></ul><ul><li>Experience in User Acceptance testing </li></ul><ul><li>Knowledge of key deliverables that impact green light milestones and vendor readiness </li></ul><ul><li>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) </li></ul> Education: <ul><li>Bachelor's degree in science or business required </li></ul><ul><li>Master's or Doctorate degree in Science or Business preferred </li></ul>

Vendor Alliance Lead Associate Director

Description

Parexel

Pipeline