Senior Remote Global Study Lead

Parexel; Lansing (MI); Remote; USD 120,000 - 180,000; Full time

Job summary

Parexel is seeking a Senior Study Manager in the United States to lead end-to-end clinical trial delivery, providing operational leadership and cross-functional oversight of the trial plan. You will build and deliver the trial operational plan, identify risks, and drive mitigations to ensure on-time, within-budget delivery in a compliant manner.

You will manage budgets, timelines, quality, and milestones; oversee CRO/vendor engagements; ensure regulatory compliance; and coach team members while

Qualifications

• BS/ BA degree is required.
• Minimum 7+ years of clinical research experience with 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.
• Accountable for overall trial delivery, budget, timelines, quality, and milestones.
• 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 SOPs.
• Participate in Health Authority inspections and internal QA audits.
• Maintain inspection-readiness and collaborate with R&D Quality for oversight.
• Mentor onboarding of new team members in Study Management.
• Interface with Finance, Vendor Management, Regulatory, Data Management, and other functions.

Skills

Cross-functional leadership

Budget oversight

Risk management

Education

BS/ BA degree

Job description

Parexel is seeking a Senior Study Manager in the United States to lead end-to-end clinical trial delivery, providing operational leadership and cross-functional oversight of the trial plan. You will build and deliver the trial operational plan, identify risks, and drive mitigations to ensure on-time, within-budget delivery in a compliant manner.

You will manage budgets, timelines, quality, and milestones; oversee CRO/vendor engagements; ensure regulatory compliance; and coach team members while