Manager, Study Start-Up & Process Improvement

ICON; Center Square (PA); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

LifeWorks EAP

Life assurance

Flexible country-specific benefits

Job summary

ICON is seeking a Manager of Study Start Up to lead the start-up activities for clinical trials, ensuring regulatory compliance and on-time site activations. You will manage end-to-end start-up, mentor a team, and collaborate with sponsors and regulatory teams to meet timelines.

Required are extensive study start-up experience, strong leadership, organizational and communication skills, and willingness to travel ~25%.

Qualifications

• 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%).

Responsibilities

• 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.

Skills

Leadership experience

Regulatory knowledge

Project management

Communication skills

Team mentoring

Strategic planning

Education

Bachelor's degree in a relevant scientific discipline

Job description

ICON is seeking a Manager of Study Start Up to lead the start-up activities for clinical trials, ensuring regulatory compliance and on-time site activations. You will manage end-to-end start-up, mentor a team, and collaborate with sponsors and regulatory teams to meet timelines.

Required are extensive study start-up experience, strong leadership, organizational and communication skills, and willingness to travel ~25%.