Senior Study Manager — Clinical Trial Delivery

Parexel; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Parexel is seeking a Senior Study Manager in the United States to lead end-to-end global clinical trials, coordinating cross-functional teams and managing budgets, timelines, and quality. The role emphasizes risk mitigation, regulatory compliance, and inspection readiness across Phase 1–4 studies.

The ideal candidate will have 7+ years of CRO/biotech/pharma experience, with strong leadership and vendor management capabilities, and the ability to travel as needed.

Qualifications

• Minimum 7+ years of clinical research experience in CRO/biotech/pharma.
• End-to-end management of Phase 1–4 global trials.
• Experience with budgets, timelines, and governance processes.

Responsibilities

• Lead the cross-functional trial team to deliver the operational plan.
• Oversee trial delivery, budget, timelines, quality, and milestones.
• Manage CRO/vendor identification, SOW creation, and KPI oversight.
• Mitigate risks and ensure regulatory compliance.
• Ensure readiness for inspections and internal QA audits.
• Mentor onboarding of new team members in Study Management.

Skills

Cross-functional leadership

Budget management

Regulatory compliance

Vendor management

Risk management

Study management

Education

BS/BA degree

Job description

Parexel is seeking a Senior Study Manager in the United States to lead end-to-end global clinical trials, coordinating cross-functional teams and managing budgets, timelines, and quality. The role emphasizes risk mitigation, regulatory compliance, and inspection readiness across Phase 1–4 studies.

The ideal candidate will have 7+ years of CRO/biotech/pharma experience, with strong leadership and vendor management capabilities, and the ability to travel as needed.