Remote Senior Clinical Trial Delivery Lead

Parexel; Montpelier (VT); On-site; USD 120,000 - 180,000; Full time

Job summary

Parexel is seeking an experienced Senior Study Manager to lead end-to-end clinical trial delivery from a cross-functional team. You will own the operational plan, manage risks, budgets, timelines, and quality, and coordinate CRO/vendor activities to ensure compliant, timely trials.

You will oversee cross-functional collaboration with Finance, Safety, Regulatory, Data Management, and QA, while guiding team members and maintaining inspection readiness across the organization.

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 end-to-end trial execution.
• Accountable for overall trial delivery, budget, timelines, quality, and milestones.
• Oversight of CRO/vendor identification, SOW creation, budget oversight and KPI tracking.
• Proactively ensure trial deliverables and milestones are met according to goals.
• Identify risks and ensure mitigations and contingencies are implemented.
• Ensure trial operations comply with global regulations and internal SOPs.
• Participate in Health Authority inspections and QA audits.
• Maintain trial team inspection-readiness and quality oversight with R&D Quality.
• Participate in process improvement at trial and department levels.
• Mentor and support onboarding of new study management members.
• Interface with key stakeholders across Finance, Program Management, Vendor Management, Safety, QA, Data Management, Clinical Research, Regulatory, and more.
• Provide variance analysis of budget to actual and alert finance to cost over/under expenditure.
• Support internal governance presentations and updates.
• Ability to travel approximately 10% with flexibility.

Skills

Clinical trial management

Budget oversight

Risk management

Vendor management

Quality assurance

Education

BS/BA degree

Job description

Parexel is seeking an experienced Senior Study Manager to lead end-to-end clinical trial delivery from a cross-functional team. You will own the operational plan, manage risks, budgets, timelines, and quality, and coordinate CRO/vendor activities to ensure compliant, timely trials.

You will oversee cross-functional collaboration with Finance, Safety, Regulatory, Data Management, and QA, while guiding team members and maintaining inspection readiness across the organization.