Senior Clinical Trial Delivery Lead - Remote

Parexel; Trenton (NJ); Sur place; USD 140 000 - 190 000; Plein temps

Résumé du poste

Parexel is seeking a Senior Study Manager in the United States to lead end-to-end clinical trial delivery, overseeing cross-functional teams to build and execute the trial operational plan. You will identify risks and drive mitigations to deliver trials on time and within budget, while ensuring compliance with global regulations and internal standards.

The role requires extensive CRO/biotech/pharma experience across Phases 1–4, strong collaboration with stakeholders, and readiness to travel.

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.

Responsabilités

• Lead 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.
• Oversight of CRO/vendor identification, 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 internal SOPs.
• Participate in Health Authority inspections and internal QA audits.
• Interface with internal stakeholders across Finance, Program Management, Vendor Management, Safety, Data Management, Biostatistics, Regulatory, QA; may act as liaison between groups.
• Provide variance analysis of budget to actual and notify finance of projected cost over/under expenditure.
• Travel approximately 10% as needed.

Formation

BS/ BA degree

Description du poste

Parexel is seeking a Senior Study Manager in the United States to lead end-to-end clinical trial delivery, overseeing cross-functional teams to build and execute the trial operational plan. You will identify risks and drive mitigations to deliver trials on time and within budget, while ensuring compliance with global regulations and internal standards.

The role requires extensive CRO/biotech/pharma experience across Phases 1–4, strong collaboration with stakeholders, and readiness to travel.