Study Start-Up Manager

ICON Strategic Solutions; United States; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health insurance

Retirement planning

Global Employee Assistance Programme (

Life assurance

Job summary

ICON plc is seeking a seasoned leader to manage day-to-day site start-up and activation activities, supporting the team to deliver quality outcomes.

You will oversee end-to-end study start-up, collaborate with sponsors and regulatory teams, and drive improvements to ensure timely initiation of clinical trials across global sites.

Qualifications

• Bachelor's degree in a relevant scientific discipline or healthcare-related field.
• Extensive experience in clinical trial study start-up with global regulatory requirements.
• Proven leadership with mentoring teams in a fast-paced, deadline-driven environment.
• Excellent organizational and project management skills.
• Strong communication and stakeholder management with sponsors and internal teams.
• Experience with process optimization and SSU plan development.
• Willingness to travel approximately 25%

Responsibilities

• Managing end-to-end study start-up activities including site identification, feasibility, regulatory submissions, and site activation.
• Leading a team of study start-up professionals, providing guidance and mentorship.
• Collaborating with sponsors, clinical operations, and regulatory teams to ensure regulatory compliance and timelines.
• Monitoring study start-up metrics, timelines, and budgets to ensure on-time delivery.
• Identifying risks and implementing mitigation strategies to prevent delays.
• Driving continuous improvement to optimize start-up processes and efficiency.

Skills

Leadership

Project management

Stakeholder management

Communication

Process optimization

Team mentorship

Education

Bachelor's degree in a relevant scientific discipline

Job description

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.

What You Will Do

You will manage day-to-day site start-up and activation activities, supporting your team to deliver quality outcomes.

Key Responsibilities Include

• 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

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 clinical trial study start-up, with a strong understanding of global regulatory requirements and clinical operations.
• 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 and the development and implementation of SSU plans
• Willingness to travel as required (approximately 25%)

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