Senior Study Manager – Remote Clinical Trial Lead

Parexel; Salem (OR); Remote; USD 120,000 - 190,000; Full time

Job summary

Parexel is seeking a Senior Study Manager to lead end-to-end clinical trial delivery, providing operational leadership across cross-functional teams and building the trial operational plan to deliver on time and within budget.

You will identify and mitigate risks, ensure compliance with global regulations, support inspections, and mentor staff while coordinating with finance, quality, and data management. Occasional travel up to 10% may be required.

Qualifications

• BS/BA degree required.
• Minimum 7+ years of clinical research experience in CRO/Biotech/Pharma managing global trials end to end.

Responsibilities

• Lead the cross-functional trial team to deliver the operational plan and end-to-end trial execution.
• Accountable for overall trial delivery, budget, timelines, quality, and milestones; support planning and deviations.
• Oversee CRO/vendor identification, SOW creation, budget oversight and KPI tracking.
• Ensure trial deliverables and milestones meet corporate and study-level goals.
• Identify risks and implement mitigations and contingencies.
• Ensure trial operations comply with global regulations and internal procedures.
• Participate in Health Authority inspections and internal QA audits.
• Maintain inspection-readiness and quality oversight with R&D Quality.
• Engage in process improvements at trial and department levels.
• Mentor and onboard new study management staff.
• Interface with Finance, Program Management, Vendor Management, Safety, QA, DM, Statistics, Regulatory, Medical Affairs; may liaison between groups.
• Provide budget variance analysis and communicate projected cost overruns/underruns.
• Support internal governance presentations and updates.
• Travel approximately 10% as needed.

Education

BS/BA degree

Job description

Parexel is seeking a Senior Study Manager to lead end-to-end clinical trial delivery, providing operational leadership across cross-functional teams and building the trial operational plan to deliver on time and within budget.

You will identify and mitigate risks, ensure compliance with global regulations, support inspections, and mentor staff while coordinating with finance, quality, and data management. Occasional travel up to 10% may be required.