Job 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

• 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) 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 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 or IOMs 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 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 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

Compliance with Parexel Standards

• Complies with required training curriculum

• Completes timesheets accurately as required

• Submits expense reports as required

• Updates CV as required

• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs, and other applicable requirements

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