East Coast Country Study Lead - CRO Operations

Parexel; Carson City (NV); On-site; USD 120,000 - 180,000; Full time

Job summary

Parexel is seeking a Country Study Manager in the United States to oversee study-level activities, vendor oversight, and country/regional CRO delivery. The role includes alignment on feasibility, target setting, risk reviews, and challenges impacting study delivery.

You will manage study operations, budgets, timelines, and regulatory documents, while coordinating with stakeholders and sponsors to ensure consistent trial execution across sites and vendors.

Qualifications

• 5+ years of clinical research experience gained with a CRO, biotech or pharmaceutical company working on phase I-IV global clinical trials
• 2-3 years leading aspects of global clinical trials
• Experience working with CROs
• Bachelor's degree is required

Responsibilities

• Manage integration of project team activities
• Manage operational studies including sites, regulatory submissions, drug supply, enrollment and budgets
• Provide input on trial level operational strategies from protocol design to final study report
• Oversee CRO/vendor identification, setup, and budget management
• Create and update trial-specific documents and training materials
• Review budgets, timelines and forecasts for assigned studies
• Support inspection readiness with risk identification and mitigation plans
• Interface with internal stakeholders and support onboarding of new team members
• Attend stakeholder meetings and provide updates on operations and progress

Skills

Decision making

Leadership

Cross-functional leadership

Mentoring

Organizational skills

Problem solving

Communication skills

Clinical documentation

Travel

Education

Bachelor's degree

Tools

MS Office

Job description

Parexel is seeking a Country Study Manager in the United States to oversee study-level activities, vendor oversight, and country/regional CRO delivery. The role includes alignment on feasibility, target setting, risk reviews, and challenges impacting study delivery.

You will manage study operations, budgets, timelines, and regulatory documents, while coordinating with stakeholders and sponsors to ensure consistent trial execution across sites and vendors.