Remote Senior Clinical Trial Delivery Lead

Parexel; Augusta (ME); On-site; USD 120,000 - 150,000; Full time

Job summary

Parexel is seeking a Senior Study Manager to lead end-to-end clinical trial delivery, providing operational leadership and cross-functional oversight to build and execute the trial plan. You will manage complexity, timelines, and budgets while ensuring quality and regulatory compliance across the program.

You will identify and mitigate risks, support Health Authority inspections, and mentor trial team members.

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.
• Oversee CRO/vendor identification, setup, SOW creation, and budget oversight.
• Identify risks and ensure mitigations and contingencies are being initiated and followed through.
• Ensure trial operations are compliant with global regulations and internal procedures.
• Participate in inspections and internal QA audits.
• Mentor and onboard new team members in Study Management.
• Interface with multiple internal stakeholders including finance, quality, data management, statistics, and regulatory.

Skills

Operational leadership

Cross-functional collaboration

Budget management

Regulatory compliance

Vendor management

Quality assurance

Risk management

Audit readiness

Education

BS/ BA degree

Job description

Parexel is seeking a Senior Study Manager to lead end-to-end clinical trial delivery, providing operational leadership and cross-functional oversight to build and execute the trial plan. You will manage complexity, timelines, and budgets while ensuring quality and regulatory compliance across the program.

You will identify and mitigate risks, support Health Authority inspections, and mentor trial team members.