Senior Study Manager

🔥 6 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👔 Manager

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Lead the cross-functional trial team and execute the operational plan for end-to-end trial execution • Oversee overall trial delivery, budget, timelines, quality, and milestones • Lead CRO/vendor identification, setup, statement of work creation, budget oversight, and performance monitoring • Ensure trial deliverables and milestones meet corporate and study-level goals • Identify risks and ensure mitigations and contingencies are initiated and followed through • Ensure trial operations comply with global health authority regulations, guidelines, and internal procedures • Participate in Health Authority Inspections and internal QA audits • Maintain trial-team inspection readiness with R&D Quality oversight • Participate in trial- and department-level process improvement activities • Mentor and support onboarding of new Study Management team members • Interface with Finance, Program Management, Vendor Management, Safety, Accounting, Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, and Medical Affairs stakeholders • Provide budget variance analysis and notify Finance of projected cost over- or under-expenditure • Support and provide input into internal governance presentations and updates

🎯 Requirements

• BS/ BA degree is required • Minimum 7+ years of clinical research experience gained with a CRO, Biotech or Pharmaceutical Company • Experience managing Phase 1-4 global clinical trials end to end • Ability to travel approximately 10% with flexibility according to business need

🏖️ Benefits

• Ability to travel approximately 10% but flexibility to go over or below as per business need • Equal opportunity employment

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