CTA

ICON is looking for a motivated and enthusiastic candidate with a background as a Medical Management Assistant who is eager to take the first steps into the world of clinical research. You'll be supported by a dedicated buddy and welcomed into a knowledgeable, experienced team.

While there's flexibility to work from home, the team regularly gathers at our Amsterdam office—conveniently located near the Amsterdam Arena—especially on Thursdays to enjoy lunch together and connect in person.

If you're ready to join a supportive team environment that will help you grow and thrive as a Clinical Trial Assistant, we’d love to hear from you—apply today!

Purpose

The Clinical Trial Associate (CTA) supports the SSO Study Start-Up Manager and the SSO Clinical Project Managerwith assigned studiesduring set-up and the wholestudy lifecycle in compliance with Novartis processes, GCP/ICH, and regulatory requirements.

Major accountabilities

• Supports the collection, preparation, and adaptation of documents for submission to IRB/EC and Health Authorities, as applicable.

• Assists in system set-up and configuration.

• Supports vendor selection, Third-Party Risk Management (TPRM) processes.

• Manages Investigator File (IF) and Trial Master File (TMF) at both country and site levels, including set-up, maintenance, document oversight, and tracking.

• Supports vendor onboarding and set-up, as applicable.

• Reviews and confirms “Green Light” readiness, ensuring all required documentation is complete for initial and subsequent drug release in collaboration with the local Qualified Person(s).

• Assists in the preparation and translation of informed consent forms (ICFs) into local languages, including vendor coordination if needed.

• Supports the preparation of patient-facing materials.

• Ensures timely and accurate upload of trial-related documents iincluding archiving of paper TMFs.

• Contributes to the development and execution of the country-level Site Start-Up (SSU) strategy in close collaboration with the SSU Team Lead and SSU Managers.

• Ensures compliance with financial controls, applicable legislation, ICH/GCP guidelines, IRB/IEC and Health Authority requirements, and internal SOPs.

• Provides logistical support to the study team throughout all phases of the clinical trial.

Education & qualifications

A degree or equivalent in a scientific of health care discipline.

Languages

Dutch, English

Experience

• Preferred, 1 + year work experience.
• Understand and apply medical and business knowledge to clinical trial execution
• Solid understanding of clinical trial design, trial execution and operations
• Knowledge of international standards (GCP), international (FDA, EMEA) and local regulations
• Expertise in communication, managing multiple priorities and computer literacy
• Excellent interpersonal skills, proven people management skills with demonstrated good expertise in teamwork.
• Collaboration across boundaries and cross-cultural experience
• Operations Management and Execution

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/benefits

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, 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-accommodations

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.