Senior Clinical Study Manager (Hybrid)
$132,100–$220,100 year
HybridMahwah, New Jersey, United States
Job Summary
Lead cross-functional projects from initiation through closeout, ensuring milestones, budgets, and timelines are achieved while developing project plans, resource forecasts, and risk mitigation strategies. Drive implementation and optimization of clinical research technology platforms by coordinating requirements, testing, deployment, and adoption activities. Partner with business, quality, IT, and vendor teams to design scalable solutions, facilitate user acceptance testing, and establish project governance structures. Maintain compliant, inspection-ready documentation and support validation, audit readiness, and regulatory compliance throughout the project lifecycle. This role supports Stryker's Joint Replacement division in delivering clinical research business initiatives through effective project execution and process improvement.
Required Qualifications
- Bachelor's degree in science or health care field
- Minimum 6 years of clinical affairs, clinical operations, and/or clinical project management experience within the device or pharmaceutical industry
- Experience leading cross-functional projects involving business process transformation, systems implementation, or operational improvement initiatives
- Experience managing multiple projects and competing priorities simultaneously
- 10% travel
Desired Qualifications
- Experience implementing or optimizing clinical technology platforms such as clinical trial management systems, electronic data capture systems, electronic trial master files, electronic clinical outcome assessment tools, analytics, reporting, or quality management systems
- Knowledge of clinical research regulations and standards, including ISO 14155
- Project Management Professional (PMP), Agile, Six Sigma, or comparable certification
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