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

Parexel; Lincoln (NE); On-site; USD 120,000 - 180,000; Full time

Job summary

Parexel, Lincoln, NE, seeks a Senior Study Manager to lead end-to-end clinical trial delivery, guiding a cross-functional team to build and execute the trial operational plan. You will identify and mitigate risks to deliver trials on time, within budget, and in compliance with regulations.

You will oversee CRO/vendor management, budget oversight, and quality milestones, while ensuring readiness for inspections and continuous process improvements. Travel ~10% as needed.

Qualifications

• Minimum 7+ years of clinical research experience in CRO, biotech or pharmaceutical company.

Responsibilities

• Lead cross-functional trial team to deliver the operational plan and end-to-end trial execution.
• Own overall trial delivery, budget, timelines, quality, and milestones including protocol deviations and resolution pathways.
• Oversee CRO/vendor selection, SOW creation, budget oversight and KPI tracking.
• Ensure trial readiness and compliance with global health authority regulations and internal SOPs.
• Support Health Authority inspections and internal QA audits; maintain inspection readiness.
• Mentor new team members and coordinate with Finance, Regulatory, QA, Data Management and others.

Education

BS/ BA degree

Job description

Parexel, Lincoln, NE, seeks a Senior Study Manager to lead end-to-end clinical trial delivery, guiding a cross-functional team to build and execute the trial operational plan. You will identify and mitigate risks to deliver trials on time, within budget, and in compliance with regulations.

You will oversee CRO/vendor management, budget oversight, and quality milestones, while ensuring readiness for inspections and continuous process improvements. Travel ~10% as needed.