Global Country Study Manager - CRO & Vendor Ops

Parexel; Topeka (KS); On-site; USD 120,000 - 180,000; Full time

Job summary

Parexel in the United States seeks a Country Study Manager to oversee study-level activities, including document creation, vendor oversight, training, and regional delivery alignment on feasibility, risk reviews, and challenges that could impact study delivery.

You will coordinate CROs, budgets, timelines, and regulatory documents, contribute to recruitment plans, and support inspection readiness while mentoring team members and interfacing with internal stakeholders.

Qualifications

• 5+ years of clinical research experience in CRO, biotech or pharma on global phase I–IV trials.
• 2–3 years leading aspects of global clinical trials.
• Experience working with CROs and vendors.

Responsibilities

• Manage integration of project team activities.
• Oversee study operations including regulatory submissions, drug supply, enrollment, document flow, timelines, budgets and data flow.
• Provide input on operational strategies from protocol design to final study report for specific studies.
• Contribute to global subject/patient recruitment plans.
• Manage CRO/vendor identification, set up, SOW creation and budget oversight.
• Create and update critical trial documents.
• Support development of training materials at compound and protocol level.
• Review budgets, timelines and forecasts for assigned studies.
• Support inspection readiness activities including risk identification and mitigation at the trial level.
• Participate in process improvement at trial and department levels.
• Manage relationships between study sites and vendors; interface with stakeholders.
• Assist onboarding of new team members; attend stakeholder meetings for updates.

Skills

Leadership

Decision-making

Analytical skills

Financial management

Cross-functional leadership

Communication

Project planning

Mentoring

Stakeholder management

Problem solving

Education

Bachelor's degree

Tools

MS Office Suite

Job description

Parexel in the United States seeks a Country Study Manager to oversee study-level activities, including document creation, vendor oversight, training, and regional delivery alignment on feasibility, risk reviews, and challenges that could impact study delivery.

You will coordinate CROs, budgets, timelines, and regulatory documents, contribute to recruitment plans, and support inspection readiness while mentoring team members and interfacing with internal stakeholders.