Clinical Trial Associate (Study Start-Up)

ICON Strategic Solutions; Paris; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

ICON plc is a world-leading healthcare intelligence and clinical research organization. We are seeking a Clinical Trial Associate in Study Start-Up to support regulatory submissions and activation activities across studies under EU CTR.

You will work with Study Start-Up Managers and cross-functional stakeholders to ensure timely preparation and activation of trials. Your profile should include a Bachelor’s degree in a scientific or healthcare field, CRO/industry Start-Up experience, and strong

Qualifications

• 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%)

Responsabilités

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

Connaissances

Organizational skills

Communication skills

Team collaboration

Attention to detail

Formation

Bachelor's degree in a scientific or healthcare-related field

Description du poste

Clinical Trial Associate

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.

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%)

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.

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