Study Start up Associate II - Regulatory

tudy Start up Associate II - Europe - home or office based

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

We are seeking a Study Start Up Associate II to join our diverse and dynamic team. In this role, you will be at the frontline of clinical research, driving the initiation of studies that bring innovative treatments and therapies closer to the patients who need them. Your work will directly support regulatory compliance, operational excellence, and the successful launch of clinical trials globally.

What you will be doing

• Lead regulatory submissions that enable trials to start on time – Prepare and submit clinical trial applications, ethics committee submissions, and communications with regulatory authorities, ensuring every study begins with the highest standards of compliance and integrity.

• Coordinate across teams and stakeholders to unlock study progress – Liaise with internal colleagues and external partners to secure approvals and authorizations, keeping studies on track and supporting patient access to innovative treatments.

• Ensure transparency and accuracy in all regulatory records – Maintain comprehensive documentation of submissions, approvals, and correspondence so that study decisions are informed, traceable, and compliant with global and local regulations.

• Empower study teams with regulatory expertise – Provide guidance and support on study start-up requirements, helping colleagues navigate complex regulatory processes efficiently and effectively.

• Drive process improvements that accelerate research – Identify opportunities to optimize start-up workflows, enhancing efficiency and contributing to ICON’s culture of quality and innovation.

Your profile

• Bachelor’s degree in Life Sciences or a related field.

• Minimum 2 years of experience in clinical research or regulatory affairs, with hands-on experience in study start-up submissions.

• Strong knowledge of ICH-GCP and local regulatory requirements.

• Fluent in English and one additional European language: German, Czech, or Dutch.

• Exceptional organizational and project management skills, able to prioritize multiple tasks and deadlines.

• Strong communication and collaboration skills, able to build effective working relationships across cross-functional teams.

• A proactive mindset and commitment to ownership, quality, and continuous improvement.

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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