Vendor Start up Manager (eCOA)

Remote, Reading·Added 7 days ago (last checked 30 Oct)

ICON plc

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Our summary

Work mode: Remote, with limits
Contract: Temporary
Experience: 3+ years
Commute: Cycle to work scheme

Skills

Requirements

What we're looking for

3+ years of experience within clinical operations, with strong expertise in vendor management and oversight.
Solid understanding of GxP, ICH-GCP, and applicable regulatory requirements.
In-depth knowledge of clinical trial design and the translation of study requirements into vendor deliverables.
Strong understanding of supplier-provided clinical services and associated operational specifications.
Demonstrated experience managing vendor relationships and collaborating with external service providers.
Proven ability to build effective partnerships with both internal and external stakeholders.
Experience leading or supporting User Acceptance Testing (UAT), particularly for eCOA and IRT platforms.
Understanding of key study start-up milestones, vendor readiness activities, and critical path deliverables.
Experience supporting outsourcing, vendor selection, contracting, and procurement processes, including RFPs and RFQs.
Expertise in one or more clinical vendor categories, such as Central Laboratories, eCOA/ePRO, IRT, Imaging, Cardiac and Respiratory Diagnostics, or Patient Recruitment and Retention (PR&R).

Nice to have

Advanced degree in a scientific, life sciences, or business-related discipline, or equivalent industry experience.

Languages

Fluent in written and spoken English.

The role

VSM - eCOA

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise.

As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

Job title - Vendor Start up Manager (eCOA) - 6 month assignment

Location - open to Eastern EU, Western EU, Bulgaria, Poland, Belgium, Netherlands, Italy, Spain and the UK

What you'll do

Working fully embedded within an ever growing program, the Vendor Start up Manager (eCOA) 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.

Review vendor and category-specific protocol requirements, ensuring supplier expertise is incorporated into final study specifications.
Support the development of Study Specification Worksheets (SSWs) to aid vendor selection and the bid process.
Partner with Procurement and vendors to evaluate proposals and quotations, providing support during contract discussions when required.
Assess and validate vendor budgets against final project scope and quotations.
Organise vendor kick-off meetings and facilitate ongoing vendor governance discussions throughout the study lifecycle.
Coordinate the collection and submission of vendor documentation required for regulatory authority submissions across participating countries.
Lead User Acceptance Testing (UAT) activities for systems such as eCOA and IRT to ensure readiness for study implementation.
Ensure protocol amendments and study design changes are effectively communicated to vendors and reflected in budgets, timelines, and service agreements.
Drive efficient study start-up activities to support timely vendor database deployment and operational readiness.
Oversee vendor performance at the study level, ensuring delivery meets agreed quality standards, timelines, and service expectations.
Identify and manage vendor-related risks, developing mitigation and contingency plans to minimise study impact.
Monitor vendor performance issues, implementing corrective actions and escalating concerns where appropriate.
Conduct root-cause analysis of supplier performance challenges and identify trends to support continuous improvement.
Contribute to the implementation of vendor management processes, templates, tools, and best practices across study start-up activities.

Experience/Professional Requirements

What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include

Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 or submit a request here

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.

Are you a current ICON Employee? Please click here to apply

About ICON plc

ICON is a clinical research organisation (CRO) providing outsourced clinical development and commercialisation services to the pharmaceutical, biotechnology and medical device industries. The company describes itself as the world's leading clinical research organisation and operates at global scale, with employees in 119 locations across 53 countries.

Its services span clinical and scientific operations, decentralised clinical trials, early clinical and laboratory services, medical imaging, regulatory affairs, consulting, commercialisation, medical writing, biometrics and outcome measures. ICON works across sectors including pharmaceuticals, biotech, medical devices and government and public health, and across therapeutic areas such as oncology, cardiovascular, central nervous system, vaccines and rare and orphan diseases.

Industry: Clinical research
Headquarters: Dublin, Ireland

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