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

ATLAS MEDICAL SERVICES LTD. STI.; United States; Remote; USD 120,000 - 190,000; Full time

Benefits offered by this job

Flexible Work Program

Bravo Recognition Program

Well-being culture

Job summary

Parexel is seeking a Senior Study Manager - FSP in the United States with remote work options. You will oversee end-to-end clinical trial delivery, lead a cross-functional team, manage budgets and timelines, and ensure compliance with global regulations.

Travel approximately 10% to support trial activities and inspections. The role requires 7+ years of CRO/biotech/pharma experience managing global trials (Phase 1–4) and a BS/BA degree.

Qualifications

• BS/BA degree required.
• 7+ years of clinical research experience, CRO/biotech/pharma, end-to-end trial management (Phase 1–4).

Responsibilities

• Lead the cross-functional trial team to deliver the operational plan and end-to-end trial execution.
• Own trial delivery, budget, timelines, quality, and milestones; support planning and deviations.
• Oversee CRO/vendor identification, SOW setup, budget oversight and KPI tracking.
• Proactively ensure milestones are met and risks are mitigated.
• 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, Program Management, Vendor Management, Safety, QA, Data Management, Statistics, Regulatory, Medical Affairs.
• Provide budget variance analysis and inform finance of cost variances.
• Support governance updates and presentations; travel ~10% as needed.

Skills

End-to-end trial delivery

Cross-functional leadership

Budget & forecasting

Risk management

Regulatory awareness

Vendor management

Education

BS/BA degree

Job description

Parexel is seeking a Senior Study Manager - FSP in the United States with remote work options. You will oversee end-to-end clinical trial delivery, lead a cross-functional team, manage budgets and timelines, and ensure compliance with global regulations.

Travel approximately 10% to support trial activities and inspections. The role requires 7+ years of CRO/biotech/pharma experience managing global trials (Phase 1–4) and a BS/BA degree.