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
We are currently seeking a Global Manager, Study Start-Up to join our diverse and dynamic team. As a Manager of Study Start-Up at ICON, you will lead and oversee the start-up activities for clinical trials on global level, ensuring that all processes are completed efficiently and in compliance with regulatory requirements. Your role will involve managing a team of professionals, working closely with cross-functional departments, and liaising with sponsors to ensure successful and timely study initiation.
What You Will Be Doing:
Managing and overseeing the end-to-end study start-up process, including site identification, feasibility, regulatory submissions, and site activation.
Leading a team of study start-up professionals, providing guidance, mentorship, and support to ensure high performance and successful project delivery.
Collaborating with sponsors, clinical operations, and regulatory teams to ensure compliance with local and global regulations and timelines for clinical trial initiation.
Monitoring study start-up metrics, timelines, and budgets to ensure projects are delivered on time and within scope.
Identifying potential risks and challenges in the start-up process and implementing strategies to mitigate delays or issues.
Driving continuous improvement initiatives to optimize the study start-up process and enhance overall efficiency.
Your Profile:
Bachelor’s degree in life sciences, clinical research, or a related field. Advanced degree or project management certification is a plus.
Extensive experience in clinical trial study start-up, with a strong understanding of global regulatory requirements and clinical operations as SSU Lead or SSU Manager.
Successful candidates must have hands-on experience with EU CTR and regulatory submissions across EMEA.
Experience supporting global studies, including involvement with US and APAC regions, is required.
Proven leadership skills, with experience managing and mentoring teams in a fast-paced, deadline-driven environment.
Excellent organizational and project management skills, with the ability to handle multiple studies and priorities simultaneously.
Strong communication and stakeholder management skills, with the ability to collaborate effectively with sponsors and internal teams.
Experience with process optimization and implementing best practices in study start-up activities.
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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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised 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? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply
Top Skills
What We Do
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.
We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
