Lead Study Start-Up Manager — Clinical Trials

Regulatory Jobs; Center Square (PA); Vor Ort; USD 110.000 - 170.000; Vollzeit

Benefits dieser Stelle

Base salary

Incentives

Health/Wellbeing

Retirement plan

Life insurance

Employee assistance

Training & development

Zusammenfassung

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.

Qualifikationen

• 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%.

Aufgaben

• 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.

Kenntnisse

Study Start-Up leadership

Team leadership

Project management

Regulatory knowledge

Stakeholder management

Communication

Process optimization

Travel readiness

Ausbildung

Bachelor's degree in science/healthcare

Jobbeschreibung

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.