Manager of Study Start Up

ICON plc • Blue Bell, SD

7d

About The Position

At ICON Strategic Solutions, the Manager of Study Start Up works in a sponsor-dedicated model, supported by ICON’s global expertise. The role leads and oversees clinical-trial start-up activities, ensuring processes are completed efficiently and in compliance with regulatory requirements. The manager oversees day-to-day site start-up and activation activities and supports the team in delivering quality outcomes.

Requirements

• 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%).
• Legal right to work in the country where the role is based.

Responsibilities

• Manage and oversee the end-to-end study start-up process, including site identification, feasibility, regulatory submissions, and site activation.
• Lead a team of study start-up professionals, providing guidance, mentorship, and support to ensure high performance and successful project delivery.
• Collaborate with sponsors, clinical operations, and regulatory teams to ensure compliance with local and global regulations and timelines for clinical trial initiation.
• Monitor study start-up metrics, timelines, and budgets to ensure projects are delivered on time and within scope.
• Identify potential risks and challenges in the start-up process and implement strategies to mitigate delays or issues.
• Drive continuous improvement initiatives to optimize the study start-up process and enhance overall efficiency.

Benefits

• Competitive base salary and performance-related incentives.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager