Senior Global Clinical Study Manager

ICON Strategic Solutions; United States; On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

Employee assistance program LifeWorks

Life assurance

Flexible country-specific benefits

Job summary

ICON Strategic Solutions is seeking a Project Manager / FSP Clinical Study Manager dedicated to a single sponsor to lead and coordinate global trial activities. You will ensure on-time, on-budget delivery to high-quality standards across studies.

Responsibilities include overseeing CRO/vendors, ensuring regulatory compliance, and maintaining inspection readiness. Strong leadership, communication, and GMP/ICH GCP knowledge are required.

Qualifications

• 5+ years in pharmaceutical industry and/or CRO.
• 3+ years of clinical study management oversight.
• Experience in early phase or Phase 2/3 studies and global/international programs.
• Experience in more than one therapeutic area is advantageous.

Responsibilities

• Support the execution of studies in compliance with ICH GCP, local regulations, and SOPs, on schedule and on budget.
• Plan and operationally execute tasks within trials; coordinate with functional leads to meet milestones and objectives.
• Oversee CRO/vendor selection, budget/contract negotiations, and supervision of performance; escalate issues to governance as needed.
• Ensure studies are inspection-ready and participate in regulatory inspections when required.
• Prepare for agency inspections, maintain document readiness, and support CSR writing and review.
• Collect/review TMF and regulatory filing documents to support trial activities.

Skills

Project management

Vendor management

Leadership

Communication

Global regulatory knowledge

PMP/PRINCE2

CTMS

Travel readiness

English fluency

Tools

CTMS

Job description

ICON Strategic Solutions is seeking a Project Manager / FSP Clinical Study Manager dedicated to a single sponsor to lead and coordinate global trial activities. You will ensure on-time, on-budget delivery to high-quality standards across studies.

Responsibilities include overseeing CRO/vendors, ensuring regulatory compliance, and maintaining inspection readiness. Strong leadership, communication, and GMP/ICH GCP knowledge are required.