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ICON plc

Manager, Study Start Up

Posted 8 Days Ago
Be an Early Applicant
Remote
Hiring Remotely in United States of America
Senior level
Remote
Hiring Remotely in United States of America
Senior level
Lead and manage end-to-end clinical trial site start-up and activation activities. Oversee site identification, feasibility, regulatory submissions, timelines, budgets, and risks. Mentor and lead a study start-up team, collaborate with sponsors and internal stakeholders, and drive process improvements to optimize start-up efficiency and compliance.
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Study Start Up Manager

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.


As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.


As a Study Start Up Manager 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.

Are you a current ICON Employee? Please click here to apply

ICON plc Chicago, Illinois, USA Office

525 W Monroe St Ste 1000, Chicago, Illinois, 60661-3791, United States, Chicago, United States, 60661-3791

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