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

Parexel; Atlanta (GA); Remote; USD 120,000 - 180,000; Full time

Job summary

Parexel is seeking a Senior Study Manager to lead end-to-end clinical trial delivery with operational leadership across cross-functional teams. You will manage risk, budget, timelines, and quality to deliver trials on time and in compliance.

In this remote US-based role, you will oversee CRO/vendor relationships, budgets, and governance, with about 10% travel to site or client meetings as needed.

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 execute delivery of the operational plan and for end-to-end trial execution.
• Oversee overall trial delivery, budget, timelines, quality and milestones; support planning and scope, with protocol deviation resolution.
• Oversee CRO/vendor identification, SOW creation, budget oversight and KPI tracking.
• Ensure trial deliverables and milestones are met according to goals and governance.
• Identify risks and implement mitigations and contingencies.
• Ensure trial operations comply with global regulations and internal SOPs.
• Assist in Health Authority inspections and internal QA audits.
• Maintain inspection-readiness with quality oversight across functions.
• Contribute to process improvement at trial and department levels.
• Mentor and onboard new team members in Study Management.
• Interface with stakeholders across Finance, Program Management, Vendor Management, Safety, QA, Data Management, Regulatory, Medical Affairs and others.
• Provide variance analysis of budget vs actual and alertFinance to potential overruns/underspends.
• Support internal governance presentations and updates.
• Travel approximately 10% as required.

Education

BS/ BA degree

Job description

Parexel is seeking a Senior Study Manager to lead end-to-end clinical trial delivery with operational leadership across cross-functional teams. You will manage risk, budget, timelines, and quality to deliver trials on time and in compliance.

In this remote US-based role, you will oversee CRO/vendor relationships, budgets, and governance, with about 10% travel to site or client meetings as needed.