Lead Clinical Systems Specialist

Pharmaceutical Research Associates, Inc; United Kingdom; Remote; GBP 60,000 - 80,000; Full time

Job summary

A leading clinical research organization in the UK is looking for a CTMS Business System Specialist to manage Veeva Vault CTMS, ensuring compliance and facilitating operations. The ideal candidate must have over 5 years of experience with Veeva Vault and a Bachelor's degree in relevant fields. The role involves designing dashboards and supporting operational trial data management. A competitive salary and various benefits are offered, fostering a diverse and inclusive work environment.

Benefits

Various annual leave entitlements

Health insurance offerings

Competitive retirement planning

Global Employee Assistance Programme

Qualifications

• 5+ years administering Veeva Vault (CTMS required); eTMF/EDC a plus.
• Working knowledge of operational data standards (e.g., CDISC/SDTM).
• Strong command of Veeva Vault Study Governance & configuration.

Responsibilities

• Monitor and maintain effective business use of the Veeva Vault CTMS.
• Support configuration, operational trial data, and compliance.
• Design dashboards for near-real-time insights.

Skills

Veeva Vault administration

Data analysis skills

SQL knowledge

Agile project management

Education

Bachelor's degree in Life Sciences, Computer Science, or related field

Tools

Power BI

Tableau

Job description

Overview

As a CTMS Business System Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities

We are looking for an agile and experienced individual to be responsible for monitoring and maintaining effective business use of the Veeva Vault CTMS (System). As the CTMS Administrator, this role will be responsible for the day-to-day management of Veeva Vault CTMS.

This role will support configuration of the platform, steward operational trial data, and partner with cross-functional teams to streamline study start-up through close-out, ensuring the system remains audit-ready, compliant, and an authoritative source of truth for program, study, country, and site information

What you will be doing:

• Serve as an administrator for Vault CTMS: manage roles/permissions, study/workflow configuration, reference data, and picklists.
• Monitor performance, schedule and validate Veeva releases (3 x’s per year), and drive enhancements or new module enablement.
• Support the establishment and enforcement of reporting, procedures and best practices for data within the configuration of the CTMS system. Help define data standards, perform routine data quality checks, and reconcile feeds from eTMF, safety, finance, and data-warehouse tools.
• Design dashboards/KPIs (enrollment, milestone burn-down, protocol deviations, monitoring visit compliance, etc.) to provide near-real-time insights to study teams and leadership.
• Support maintenance of validation pack, traceability matrices, and audit trails to meet GxP, ICH-GCP, and 21 CFR Part 11 requirements.
• Support internal/health-authority inspections by supplying system evidence and responding to findings.
• Support the development of SOPs, quick-reference guides, and deliver live/recorded training for new functionality or process changes.

Qualifications

You are:

• Bachelor’s degree in Life Sciences, Computer Science, Information Systems, or related field.
• 5 + years administering Veeva Vault (CTMS required; eTMF/EDC a plus) and 7 + years with clinical trial technologies overall.
• Veeva Vault Admin or Business-Admin certification(s) preferred.
• Strong command of Veeva Vault Study Governance & Vault CTMS configuration, security model, and object lifecycle management.
• Working knowledge of operational data standards (e.g., CDISC/SDTM), SQL or report-building tools (Power BI/Tableau), and integration patterns (APIs, flat-file, middleware).
• Demonstrated understanding of clinical trial phases, study-startup through close-out activities, and global regulations governing electronic systems (GxP, 21 CFR Part 11, GDPR).
• Analytical mindset, ability to translate business needs into system solutions, clear written/verbal communication, and aptitude for teaching adult learners.
• Familiarity with eTMF, Safety, Quality, or Regulatory Vaults and their cross-module data flows.
• Exposure to agile project management and validation methodologies (CSV, GAMP 5).

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 maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt 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, 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 through the form below. https://careers.iconplc.com/reasonable-accommodationsInterested 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.

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