Clinical Trial Manager - Regulatory Submissions

Clinical Trial Manager - Regulatory & Study Start Up

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%)

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