Clinical Trial Submission Coordinator

ICON Clinical Research; España; A distancia; EUR 90.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual leave

Health insurance

Retirement planning

Employee assistance program

Life assurance

Descripción de la vacante

ICON Strategic Solutions is seeking a Principal, Study Start Up Associate to lead clinical trial start-up activities. You will coordinate site activation, ensure regulatory compliance, and collaborate with project management, clinical operations, and regulatory affairs to streamline processes.

The role requires solid start-up experience, strong organizational skills, and the ability to travel about 15% to support sites globally.

Formación

• Solid site start-up and activation experience.
• Ability to manage multiple projects and priorities in a fast-paced environment.
• Excellent organizational skills and attention to detail.
• Willingness to travel approximately 15%.

Responsabilidades

• Leading the preparation and submission of essential documents for regulatory approvals and site activation.
• Collaborating with cross-functional teams, including project management, clinical operations, and regulatory affairs, to streamline study start-up processes.
• Overseeing the identification and selection of clinical sites, ensuring they meet project criteria and compliance standards.
• Providing guidance and support to study teams and sites during the start-up phase, fostering effective communication and collaboration.
• Staying current with industry regulations and trends to enhance start-up strategies and best practices.

Conocimientos

Site start-up experience

Project coordination

Regulatory knowledge

Communication skills

Educación

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

Descripción del empleo

POL-Start Up- HB

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Principal, Study Start Up Associate at ICON, you will be responsible for leading the start-up activities for clinical trials, ensuring efficient site activation and compliance with regulatory requirements.

What You Will Do:

Your focus will be on coordinating site start-up and activation delivery, resolving issues, and developing team capability.

Key responsibilities include:

• Leading the preparation and submission of essential documents for regulatory approvals and site activation.
• Collaborating with cross-functional teams, including project management, clinical operations, and regulatory affairs, to streamline study start-up processes.
• Overseeing the identification and selection of clinical sites, ensuring they meet project criteria and compliance standards.
• Providing guidance and support to study teams and sites during the start-up phase, fostering effective communication and collaboration.
• Staying current with industry regulations and trends to enhance start-up strategies and best practices.

Your Profile:

You will have solid site start-up and activation experience, with the ability to manage competing priorities and develop your team.

Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare-related field
• Extensive experience in study start-up activities within the clinical research industry, with a strong understanding of regulatory requirements.
• Proven ability to manage multiple projects and prioritize tasks effectively in a fast-paced environment.
• Excellent organizational skills and attention to detail, with a commitment to delivering high-quality results.
• Strong communication and interpersonal skills, enabling effective collaboration with diverse teams and external stakeholders.
• A commitment to maintaining high standards of quality and compliance in all study start-up activities.
• Willingness to travel as required (approximately 15%)

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.