Remote Senior Study Manager: End-to-End Clinical Trials

Parexel; Honolulu (HI); Remote; USD 120,000 - 160,000; Full time

Job summary

Parexel is seeking a Senior Study Manager to lead end-to-end delivery of global clinical trials from our Honolulu area. You will provide operational leadership, oversee cross-functional teams, and ensure on-time, within-budget delivery while maintaining compliance with global regulations and internal procedures.

You will manage vendor relationships, budgets, risk mitigation, and quality oversight, with occasional travel and collaboration with multiple functional areas to support study success.

Qualifications

• BS/ BA degree is required.
• Minimum 7+ years of clinical research experience in CRO/biotech/pharma.
• Experience managing Phase 1-4 global trials end to end.

Responsibilities

• Lead cross-functional trial team to deliver the operational plan.
• Own trial delivery, budget, timelines, quality, and milestones.
• Oversee CRO/vendor identification, SOW creation, and budget oversight.
• Ensure milestones and deliverables meet goals and comply with regulations.
• Identify risks and implement mitigations and contingencies.
• Maintain inspection-readiness and quality oversight with QA.
• Mentor onboarding of new team members in Study Management.
• Interface with stakeholders across Finance, Regulatory, Data Management, and more.
• Provide variance analysis of budget to actual and report to finance.
• Travel approximately 10% as needed.

Skills

Clinical trial management

Budget oversight

Risk management

Vendor management

Education

Bachelor's degree in life sciences

Job description

Parexel is seeking a Senior Study Manager to lead end-to-end delivery of global clinical trials from our Honolulu area. You will provide operational leadership, oversee cross-functional teams, and ensure on-time, within-budget delivery while maintaining compliance with global regulations and internal procedures.

You will manage vendor relationships, budgets, risk mitigation, and quality oversight, with occasional travel and collaboration with multiple functional areas to support study success.