Global Study Operations Lead - East Coast (CRO & Vendors)

Parexel; Lincoln (NE); On-site; USD 120,000 - 160,000; Full time

Job summary

Parexel is seeking a Country Study Manager to lead and oversee study-level activities across trials, ensuring alignment on feasibility strategies, risk management, and country challenges impacting delivery. You will coordinate CROs, vendors, vendors, training, and critical documents while guiding global operations and stakeholder communications.

The role requires deep clinical research experience, leadership in cross-functional teams, and the ability to manage budgets, timelines, and quality

Qualifications

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

Responsibilities

• Manage integration of project team activities.
• Oversee study operations including regulatory submissions, drug supply, enrollment, timelines, budgets, and data flow.
• Provide input on trial level operational strategies from protocol design to final study report.
• Provide input into global recruitment plans and CRO/vendor management.
• Create and update critical trial documents and training materials.
• Review budgets, timelines, and forecasts; support inspection readiness.
• Interface with stakeholders and support onboarding of new team members.
• Attend stakeholder meetings and provide progress updates on operations.

Skills

Decision-making

Leadership

Project planning

Cross-functional collaboration

Analytical thinking

Communication (oral/written)

Sponsor/vendor management

Travel readiness

Education

Bachelor's degree

Tools

MS Office

Excel

Word

PowerPoint

Job description

Parexel is seeking a Country Study Manager to lead and oversee study-level activities across trials, ensuring alignment on feasibility strategies, risk management, and country challenges impacting delivery. You will coordinate CROs, vendors, vendors, training, and critical documents while guiding global operations and stakeholder communications.

The role requires deep clinical research experience, leadership in cross-functional teams, and the ability to manage budgets, timelines, and quality