Clinical Trial Associate (Study Start-Up)

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

As Clinical Trial Associate in Study Start-Up, you will play a key role in supporting and coordinating clinical trial start-up activities across multiple studies under the European Clinical Trial Regulation (EU CTR). Working closely with Study Start-Up Managers and cross-functional stakeholders, you will contribute to the timely preparation and execution of regulatory submissions and study activation activities.

What You Will Do:

Your role will involve delivering clinical research work to a high standard, working closely with your team and stakeholders.

Key responsibilities include:

• Supporting the preparation and coordination of EU CTR submission packages for initial applications and substantial amendments.
• Coordinating submission timelines and tracking critical milestones to ensure timely study start-up execution.
• Collaborating with local study teams, Study Start-Up Managers, Medical Advisors and other stakeholders to ensure country readiness before submission
• Managing interactions with external translation vendors and coordinating document translation activities.
• Supporting the management of Requests for Information (RFIs), including timeline tracking, response coordination and follow-up with internal stakeholders.
• Supporting the coordination of Investigational Medicinal Product (IMP) supply activities during study start-up.
• Supporting French-specific regulatory declarations and notifications with relevant authorities and healthcare professionals when required

Your Profile:

You will bring relevant clinical research experience, along with the following qualifications and skills.

Required qualifications and experience:

• Bachelor's degree in a scientific or healthcare-related field.
• Experience supporting Study Start-Up activities within a CRO, pharmaceutical company or clinical research environment.
• Knowledge of clinical trial processes, regulations, and guidelines.
• Knowledge of European Clinical Trial Regulation (EU CTR) processes.
• Excellent organizational and communication skills.
• Ability to work collaboratively in a fast-paced environment with attention to detail.
• Willingness to travel as required (approximately 10%)

#LI-SB2

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

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

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

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