Job Description

Overview

As a Vendor Startup Manager you will be joining the world\xe2\x80\x99s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities

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.

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

Qualifications

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 \xe2\x80\x93 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\xe2\x80\x99s why we are committed to developing our employees in a continuous learning culture \xe2\x80\x93 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 \xe2\x80\x93 there\xe2\x80\x99s every chance you\xe2\x80\x99re exactly what we\xe2\x80\x99re looking for here at ICON whether it is for this or other roles.

ICON