Remote Senior Study Manager — End-to-End Clinical Trials

Parexel; Austin (TX); Remote; USD 150,000 - 190,000; 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 coordination to build and deliver the trial operational plan.

You will identify and mitigate risks to ensure trials are delivered on time, within budget, and in compliance with global regulations, while guiding a cross-functional team and engaging with stakeholders across the organization.

Qualifications

• BS/ BA degree is required.
• Minimum 7+ years of clinical research experience with a CRO, Biotech or Pharmaceutical Company managing on Phase 1-4 global clinical 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.
• Oversight of CRO/vendor identification, set up, statement of work creation, budget oversight and KPI tracking.
• Proactively ensure that trial deliverables and milestones are met according to goals.
• Identify risks and ensure mitigations and contingencies are initiated and followed through.
• Ensure trial operations are compliant with global health authority regulations and internal procedures.
• Participate in preparation for, and conduct of, Health Authority Inspections and internal QA audits.
• Ensure trial team remains inspection-ready, collaborating with R&D Quality for oversight.
• Participate in process improvement activities at trial and department level.
• Mentor and support onboarding of new team members in Study Management.
• Interface with internal stakeholders across Finance, Program Management, Vendor Management, Safety, Accounting, Supply, QA, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, Medical Affairs.
• Provide a variance analysis of budget to actual and notify finance of projected cost over/under expenditure.
• Support input into internal governance presentations and updates.
• Ability to travel approximately 10% but flexible per business needs.

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 coordination to build and deliver the trial operational plan.

You will identify and mitigate risks to ensure trials are delivered on time, within budget, and in compliance with global regulations, while guiding a cross-functional team and engaging with stakeholders across the organization.