Clinical Trial Submission Coordinator

ICON Strategic Solutions; España; On-site; EUR 80,000 - 110,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance options

Retirement planning options

Employee assistance program

Job summary

ICON plc is seeking a Principal, Study Start Up Associate to lead start-up activities and drive site activation for clinical trials. You will ensure regulatory compliance, coordinate cross-functional efforts, and optimize start-up processes across teams.

The role requires extensive start-up experience, strong communication, and the ability to manage multiple projects in a fast-paced environment. Travel up to ~15% is expected.

Qualifications

• Bachelor’s degree in a relevant scientific field.
• Extensive experience in study start-up activities with regulatory knowledge.
• Ability to manage multiple projects and priorities.

Responsibilities

• Lead start-up activities and site activation delivery.
• Coordinate regulatory submissions and essential documents.
• Collaborate with PM, clinical operations, and regulatory teams.
• Identify and qualify clinical sites meeting project criteria.
• Provide guidance to study teams and sites during start-up.

Skills

Site start-up experience

Regulatory knowledge

Communication skills

Project prioritization

Team leadership

Education

Bachelor’s degree in a relevant scientific discipline

Job description

POL-Start Up- HB

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 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.

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?