Global Clinical Study Operations Lead

Parexel; Madison (WI); On-site; USD 120,000 - 180,000; Full time

Job summary

Parexel is seeking a Country Study Manager to oversee study-level activities across global trials. You will create trial documents, oversee CROs, manage budgets, and ensure delivery of timelines and regulatory readiness.

You will lead cross-functional teams, mentor staff, and collaborate with stakeholders to optimize feasibility, enrollment, and risk management. Travel about 10% to support sites.

Qualifications

• 5+ years of clinical research experience in CRO/biotech/pharma on global trials (Phase I–IV).
• 2–3 years leading aspects of global clinical trials.
• Experience working with CROs.

Responsibilities

• Manage integration of project team activities.
• Oversee study operations including sites, regulatory submissions, enrollment, budgets, timelines, and data flow.
• Provide input on trial-level operational strategies from protocol design to final study report.
• Provide input into global subject/patient recruitment plans.
• Manage CRO/vendor identification and day-to-day management.
• Create and update critical trial-specific documents.
• Support development of compound and protocol-level training materials.
• Review budgets, timelines, and forecasts for assigned studies.
• Support inspection readiness activities including risk identification and mitigation.
• Attend stakeholder meetings and provide updates on operational progress.

Education

Bachelor's degree

Job description

Parexel is seeking a Country Study Manager to oversee study-level activities across global trials. You will create trial documents, oversee CROs, manage budgets, and ensure delivery of timelines and regulatory readiness.

You will lead cross-functional teams, mentor staff, and collaborate with stakeholders to optimize feasibility, enrollment, and risk management. Travel about 10% to support sites.