Study Start-Up Manager | Lead Trials & Compliance

ICON Strategic Solutions; United States; On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance offerings

Retirement planning offerings

Global Employee Assistance Programme (

Life assurance

Flexible country-specific benefits

Job summary

ICON Strategic Solutions is seeking a Manager, Study Start Up to lead end-to-end site start-up activities for clinical trials, ensuring regulatory compliance and timely activation across sponsors and sites.

You will manage day-to-day start-up operations, mentor a team of start-up professionals, collaborate with sponsors, regulatory teams, and clinical operations, and drive continuous improvement while traveling about 25%.

Qualifications

• Bachelor's degree in a relevant scientific discipline or healthcare-related field.
• Extensive experience in clinical trial study start-up with global regulatory knowledge.
• Proven leadership in fast-paced, deadline-driven environments.
• Strong organizational and project management skills with multiple studies.
• Excellent communication and stakeholder management with sponsors and teams.
• Willingness to travel approximately 25%.

Responsibilities

• Manage end-to-end study start-up and site activation processes.
• Lead a team of study start-up professionals with mentorship and guidance.
• Collaborate with sponsors, clinical operations, and regulatory teams for compliance and timelines.
• Monitor start-up metrics, timelines, and budgets to ensure on-time delivery.
• Identify risks and implement strategies to mitigate delays.
• Drive continuous improvement to optimize the study start-up process.

Skills

Leadership

Stakeholder management

Project management

Regulatory knowledge

Communication

Education

Bachelor's degree in a relevant scientific discipline or healthcare-related field

Job description

ICON Strategic Solutions is seeking a Manager, Study Start Up to lead end-to-end site start-up activities for clinical trials, ensuring regulatory compliance and timely activation across sponsors and sites.

You will manage day-to-day start-up operations, mentor a team of start-up professionals, collaborate with sponsors, regulatory teams, and clinical operations, and drive continuous improvement while traveling about 25%.