Vendor Start Up Manager (Central Lab) - Remote

Overview

Reporting to the Vendor Category Expert, the Vendor Startup Manager is responsible to provide technical expertise for a given category during study startup to the VPM Vendor Program Manager and indirectly to the study start-up team.

 

The VSM enables a flawless and accelerated vendor service delivery at the trial start-up phase and supports implementation of defined category strategies and service standardization.

This role proactively assesses risk and concludes contingency plans to de-risk study startup.

Responsibilities

What you will be doing:

• Reviewing of the vendor and category related specific sections of the protocol, ensure vendor expertise is leveraged when refining specifications towards Final Protocol
• Contributing to development of Study Specification Worksheet (SSW) to facilitate bid process and selection of Vendors.
• Quote/Proposal review in collaboration with procurement (and vendor). If required, support contract negotiations.
• Vendor budget review of final quotes
• Co-ordinates vendor kick-off meeting and other vendor specific meetings
• Collects HA submission documents from vendor, as requested by countries participating in a study
• Performs robust User Acceptance Testing (UAT) for eCOA and IRT
• Ensures changes to protocol or study designs are consistently shared with vendors and incorporated into supplier budgets, timelines, and specifications. Supports amendment of vendor contracts with Procurement team
• Optimizing a frontloaded and timely study start-up process in support of a timely vendor DB-go-live
• Vendor service excellence at study level, ensures vendors meet quality and service level standards in their service delivery for the trial
• Pro-actively creates and maintains vendor related risk maps with contingency plan for documentation in FIRST
• Document issues identified with vendor oversight / performance in FIRST tool and implements and monitors corrective actions. Escalates issue if required to the Vendor Category Expert VCE.
• Drive root cause analysis of supplier performance issues and look for trending
• Supports the implementation of standards, templates, tools, and processes for vendors at SSU for defined categories in collaboration with the VCE
• Using Unified Vendor Portal (UVP) to manage vendor service delivery
• Supports practice leaders in improvement projects and learning loops
• Collaborate with VP&G to provide data for vendor qualification efforts#LI-AS2

Qualifications

You are:

• Bachelors degree
• 3+ 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
• Thorough and technical understanding of Novartis specifications for supplier provided services
• Demonstrated leadership with supplier relationship management and/or expert knowledge of specific service areas
• Demonstrated partnering across divisions with internal and external stakeholders
• Demonstrated root cause analysis, problem solving, and solution generation skills
• Experience in User Acceptance testing (eCOA & IRT)
• Knowledge of key deliverables that impact green light milestones and vendor readiness
• Experience in outsourcing, contracting, sourcing of clinical services with Vendor/CROs (RFP, RFQ, contracting)
• Specific category expertise - specifically such as Central Labs, eCOA/ePRO, IRT, Cardiac and Respiratory diagnostics, PR&R, Imaging reading.

Why ICON?Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

Employment Type: OTHER