Senior Clinical Trial Delivery Lead

Parexel; Richmond (VA); On-site; USD 130,000 - 170,000; Full time

Job summary

Parexel in the United States is seeking a Senior Study Manager to lead end-to-end clinical trial delivery, guiding a cross-functional team to build and execute the trial operational plan.

You will manage budgets, timelines, quality, and regulatory compliance, oversee CRO/vendor relationships, and drive process improvements while ensuring inspection readiness and travel about 10%.

This role requires strong leadership, strategic oversight, and hands-on collaboration with internal stakeholders.

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 (e.g., support DBL/ CSR/ TLR planning and scope, define protocol deviations and resolution pathways).
• Oversight of CRO/vendor identification, set up, statement of work creation, budget oversight and performance (KPI’s and metrics)
• Proactively ensure that trial deliverables and milestones are met according to corporate and study-level goals
• Identify risks and ensure mitigations and contingencies are being initiated and followed through
• Ensure trial is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes
• Participate in preparation for, and conduct of, Health Authority Inspections and internal QA audits
• Ensure that the trial team operates in a constant state of inspection-readiness, collaborating with R&D Quality to ensure quality oversight
• Participate in process improvement activities at a trial and department level as needed
• Mentor & support onboarding of new team members, particularly those in Study Management.
• Interface with internal key stakeholders including, but not limited to; Finance, Program Management, Vendor Management, Safety, Accounting, Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, Medical Affairs; which may include acting as a liaison between groups.
• Provide a variance analysis of budget to actual and notify finance of projected cost over/under expenditure.
• Support and provide input into internal governance presentations & updates
• Ability to travel approximately 10% but flexibility to go over or below as per business need)

Skills

Cross-functional leadership

Budget management

Risk management

Vendor management

QA oversight

Project management

Education

BS/BA degree

Job description

Parexel in the United States is seeking a Senior Study Manager to lead end-to-end clinical trial delivery, guiding a cross-functional team to build and execute the trial operational plan.

You will manage budgets, timelines, quality, and regulatory compliance, oversee CRO/vendor relationships, and drive process improvements while ensuring inspection readiness and travel about 10%.

This role requires strong leadership, strategic oversight, and hands-on collaboration with internal stakeholders.