Remote Senior Study Manager - End-to-End Trials Lead

Parexel; Helena (MT); Remote; USD 130,000 - 170,000; Full time

Job summary

Parexel is seeking a Senior Study Manager in the United States to lead end-to-end clinical trial delivery. You will oversee cross-functional teams, manage budgets, timelines, quality, and milestones while ensuring regulatory compliance and readiness for inspections.

The role includes mentoring new staff and collaborating with multiple internal stakeholders. Applicants should bring significant CRO/biotech/pharma experience across Phase 1–4 trials, with a focus on risk management and process

Qualifications

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

Responsibilities

• Lead 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, set up, SOW creation, budget oversight and KPIs.
• Proactively ensure trial deliverables and milestones meet goals.
• Identify risks and implement mitigations and contingencies.
• Ensure trial operations comply with global regulations and internal SOPs.
• Participate in inspections and internal QA audits.
• Maintain an inspection-ready trial team with QA oversight.
• Contribute to process improvement at trial and department levels.
• Mentor and onboard new team members in Study Management.
• Interface with Finance, Program Management, Vendor Management, Safety, QA, Data Management, Regulatory and more.
• Provide budget variance analyses and notify finance of projections.
• Support and input into internal governance updates.
• Willingness to travel ~10% as needed.

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. You will oversee cross-functional teams, manage budgets, timelines, quality, and milestones while ensuring regulatory compliance and readiness for inspections.

The role includes mentoring new staff and collaborating with multiple internal stakeholders. Applicants should bring significant CRO/biotech/pharma experience across Phase 1–4 trials, with a focus on risk management and process