Senior Study Manager: Remote Clinical Trial Delivery

Parexel; Denver (CO); Remote; USD 120,000 - 160,000; Full time

Job summary

Parexel is seeking a Senior Study Manager in the United States to lead end-to-end clinical trial delivery. The role oversees cross-functional teams, manages budgets and timelines, and ensures compliance with global health authority regulations.

The successful candidate will drive risk management, supplier oversight, and governance updates, while mentoring new team members and collaborating with key stakeholders across the organization. Travel is expected around 10%.

Qualifications

• BS/BA degree is required.
• Minimum 7+ years of clinical research experience gained with a CRO, Biotech or Pharmaceutical Company managing on Phase 1-4 global clinical trials end to end.

Responsibilities

• Lead the cross functional trial team to influence and execute delivery of the operational plan and for end-to-end trial execution.
• Accountable for overall trial delivery, budget, timelines, quality, and milestones; support DBL/CSR/TLR planning and protocol deviations.
• Oversight of CRO/vendor identification, budget oversight and KPI tracking.
• Ensure trial readiness and compliance with global health authority regulations and internal SOPs.
• Mentor onboarding of new team members in Study Management.
• Interface with internal stakeholders across Finance, Program Management, Vendor Management, Safety, Quality Assurance, Data Management, Regulatory; liaise between groups.
• Provide variance analysis of budget to actual and notify finance of cost projections.
• Support internal governance presentations and updates.
• Travel approximately 10% with flexibility.

Skills

Clinical trial management

Cross-functional leadership

Budgeting & forecasting

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. The role oversees cross-functional teams, manages budgets and timelines, and ensures compliance with global health authority regulations.

The successful candidate will drive risk management, supplier oversight, and governance updates, while mentoring new team members and collaborating with key stakeholders across the organization. Travel is expected around 10%.