Remote Senior Study Manager - End-to-End Trials

Parexel; Olympia (WA); On-site; USD 120,000 - 160,000; Full time

Job summary

Parexel is seeking a Senior Study Manager to lead end-to-end clinical trial delivery with cross-functional teams. The role focuses on operational plans, risk mitigation, budget oversight, and ensuring compliance with global regulations and internal SOPs.

The ideal candidate has 7+ years of clinical research experience in CRO/biotech/pharma settings and holds a BS/BA degree. Travel is expected at times to support inspections and governance activities.

Qualifications

• BS/ BA degree is required.
• Minimum 7+ years of clinical research experience with a CRO, Biotech or Pharmaceutical Company managing Phase 1-4 global trials end to end.

Responsibilities

• Lead the cross-functional trial team to deliver the operational plan and end-to-end trial execution.
• Own overall trial delivery, budget, timelines, quality and milestones; support protocol deviations and resolution pathways.
• Oversee CRO/vendor identification, SOW creation, budget oversight and KPI tracking.
• Ensure trial milestones meet corporate and study-level goals.
• Identify risks and implement mitigations and contingencies.
• Ensure trial operations comply with global regulations and internal SOPs.
• Participate in inspections and QA audits; maintain inspection readiness.
• Collaborate with internal stakeholders across departments; liaise between groups as needed.
• Provide variance analysis of budget to actual and communicate forecasts to finance.

Skills

Cross-functional leadership

Clinical trial management

Budget oversight

Risk management

Education

BS/ BA degree

Job description

Parexel is seeking a Senior Study Manager to lead end-to-end clinical trial delivery with cross-functional teams. The role focuses on operational plans, risk mitigation, budget oversight, and ensuring compliance with global regulations and internal SOPs.

The ideal candidate has 7+ years of clinical research experience in CRO/biotech/pharma settings and holds a BS/BA degree. Travel is expected at times to support inspections and governance activities.