Manager of Study Start Up

Regulatory Jobs; Center Square (PA); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Base salary

Incentives

Health/Wellbeing

Retirement plan

Life insurance

Employee assistance

Training & development

Job summary

ICON Strategic Solutions, a leading FSP organisation, seeks a Manager of Study Start Up to lead end-to-end site activation for clinical trials. You will manage regulatory submissions, feasibility and activation while guiding a high-performing team in a sponsor-dedicated model.

You will collaborate with sponsors and regulatory teams to ensure global compliance, monitor timelines and budgets, and drive process improvements. Travel about 25% to sites as required.

Qualifications

• Bachelor's degree in a relevant scientific discipline or healthcare field.
• Extensive experience in clinical trial study start-up and regulatory requirements.
• Proven leadership and team-mentoring experience in a fast-paced environment.
• Strong organizational and project management skills to handle multiple studies.
• Excellent communication and stakeholder management with sponsors and internal teams.
• Experience with process optimization and implementing best practices in study start-up.
• Willingness to travel approximately 25%.

Responsibilities

• Oversee day-to-day site start-up and activation activities and guide the team to quality outcomes.
• Manage end-to-end study start-up: site identification, feasibility, regulatory submissions, site activation.
• Lead a team of start-up professionals with mentorship and performance support.
• Collaborate with sponsors, clinical operations, and regulatory teams to ensure regulatory compliance and timelines.
• Monitor start-up metrics, timelines, and budgets to keep projects on schedule and within scope.
• Identify risks in start-up processes and implement mitigation strategies.
• Drive continuous improvement to optimize start-up efficiency.

Skills

Study Start-Up leadership

Team leadership

Project management

Regulatory knowledge

Stakeholder management

Communication

Process optimization

Travel readiness

Education

Bachelor's degree in science/healthcare

Job description

Manager of 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 Manager, Study Start Up at ICON, you will lead and oversee the start-up activities for clinical trials, ensuring that all processes are completed efficiently and in compliance with regulatory requirements.

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.
• Willingness to travel as required (approximately 25%)

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.