Senior Study Manager
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Job Description
Senior Study Manager leading Parexel’s end-to-end global clinical trial delivery. Overseeing cross-functional teams, vendors, budgets, risks, timelines, and regulatory compliance.
Responsibilities:
- 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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