Global Country Study Operations Lead

Parexel; Trenton (NJ); Vor Ort; USD 120.000 - 180.000; Vollzeit

Zusammenfassung

Parexel in New Jersey seeks a Country Study Manager to oversee study-level activities, including document creation, vendor oversight, and regional delivery of CRO operations.

You will align feasibility, target setting, risk reviews, and country challenges with global strategies, while ensuring on-time study execution and compliance. Extensive collaboration with internal stakeholders and vendors is required.

Qualifikationen

• 5+ years of clinical research experience in a CRO/biotech/pharma
• 2-3 years leading global clinical trials
• Experience working with CROs and vendors

Aufgaben

• Oversee integration of project team activities
• Manage study sites, regulatory submissions, drug supply, enrollment, and data flow
• Contribute to protocol design and trial level operational strategies
• Support CRO/vendor identification, setup, and budget oversight
• Create and update trial-specific documents
• Assist in training materials for compounds and protocols
• Review budgets, timelines, and forecasts for studies
• Support inspection readiness and risk mitigation at trial level
• Participate in process improvements at trial and department levels
• Coordinate with study sites, vendors and internal stakeholders
• Assist onboarding of new team members
• Attend stakeholder meetings and provide progress updates

Kenntnisse

Decision-making

Leadership

Mentoring

Organizational skills

Communication

Travel ability

Project management

MS Office

Ausbildung

Bachelor's degree

Tools

MS Office Suite

Jobbeschreibung

Parexel in New Jersey seeks a Country Study Manager to oversee study-level activities, including document creation, vendor oversight, and regional delivery of CRO operations.

You will align feasibility, target setting, risk reviews, and country challenges with global strategies, while ensuring on-time study execution and compliance. Extensive collaboration with internal stakeholders and vendors is required.