Senior Clinical Trial Operations Lead (Remote)

Parexel; Topeka (KS); On-site; USD 110,000 - 160,000; Full time

Job summary

Parexel in the United States is seeking a Senior Study Manager to lead end-to-end clinical trial delivery. You will oversee cross-functional teams, manage budgets, timelines and quality, and ensure compliance with global regulations and internal SOPs.

The role involves risk identification and mitigation, governance participation, and collaboration with multiple stakeholders. Travel up to 10% may be required to support inspections and vendor oversight.

Qualifications

• Must have 7+ years of clinical research experience with a CRO, biotech or pharmaceutical company.
• BS/BA degree is required.

Responsibilities

• Lead cross-functional trial team to execute the operational plan and end-to-end trial delivery.
• Accountable for overall trial delivery, budget, timelines, quality, and milestones.
• Oversee CRO/vendor identification, SOA creation, budget oversight and KPI tracking.
• Proactively ensure trial deliverables and milestones meet goals.
• Identify risks and implement mitigations and contingencies.
• Ensure trial conduct complies with global health authority regulations and internal SOPs.
• Participate in Health Authority inspections and internal QA audits.
• Ensure trial team remains inspection-ready with QA oversight.
• Engage in process improvements at trial and department levels.
• Mentor onboarding of new team members in Study Management.
• Interface with stakeholders across Finance, Quality, Data Mgmt, Regulatory, etc.
• Provide variance analysis of budget to actual and flag cost trends.
• Support internal governance presentations and updates.
• Travel approximately 10% as needed.

Skills

Cross-functional leadership

Budget management

Regulatory compliance

Vendor management

Quality oversight

Risk management

Education

BS/BA degree

Job description

Parexel in the United States is seeking a Senior Study Manager to lead end-to-end clinical trial delivery. You will oversee cross-functional teams, manage budgets, timelines and quality, and ensure compliance with global regulations and internal SOPs.

The role involves risk identification and mitigation, governance participation, and collaboration with multiple stakeholders. Travel up to 10% may be required to support inspections and vendor oversight.