Vendor Start Up Manager - Ecoa

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

You will be partnering with one of our global pharmaceutical clients; a science-based company with one of the most exciting product pipelines in the industry. This global pharmaceutical client develops breakthrough innovative medicines to improve and extend the opportunity to build your career in a rewarding customer-focused environment that supports creativity, collaboration and performance

As Vendor Start Up Manager - Ecoa you will be responsible for: 

• Reviewing of the vendor and category related specific sections of the protocol
• Ensuring 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), supporting contract negotiations.
• Vendor budget review of final quotes
• Co-ordinating vendor kick-off meeting and other vendor specific meetings
• Collecting HA submission documents from vendor, as requested by countries
• Performing robust User Acceptance Testing (UAT) for eCOA and IRT
• Ensuring changes to protocol or study designs are consistently shared with vendors and incorporated into supplier budgets, timelines, and specifications.
• Supporting 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 creating and maintaining 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.
• Driving root cause analysis of supplier performance issues and look for trending.
• Supporting 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
• Collaborating to provide data for vendor qualification efforts

• Advanced degree in science or business with equivalent experience
• 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
• 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.
  
  Benefits of Working in ICON:
  
  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.
  
  At 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.
  
  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, color, 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.