Senior Clinical Study Manager (Remote) 

Stryker is hiring a Senior Clinical Study Manager to support our Medical Division. In this role you will be responsible for executing the clinical evidence strategy for medical devices, and support the development of this strategy, to enable new and continued global market access. 

Work Flexibility: Remote - Preferred location is the Midwest or Eastern United States

What you will do 

• Manage day-to-day operations of one or more clinical studies, ensuring compliance with GCP, FDA regulations, and internal procedures.
• Develop and maintain study-specific documents, including protocols, amendments, monitoring plans, and operational guidelines.
• Oversee data collection, validation, and documentation to meet quality standards and timelines.
• Coordinate and support field-monitoring activities; track enrollment curves and study milestones.
• Assess project risks and implement mitigation strategies to ensure deliverables are achieved.
• Initiate and manage research contracts for Investigator-Initiated Studies and ensure alignment with research strategy.
• Drive publication of study results in peer-reviewed journals by collaborating with internal and external stakeholders.
• Maintain dashboards for clinical and non-clinical studies, tracking objectives, timelines, and financial aspects.
• Oversees clinical documentation to validate device safety and performance for regulatory body submissions and perform periodic updates to maintain compliance (e.g., CERs, CEPs, PMCFRs, PMCFPs, SSCPs). 
• Supporting Marketing in the creation and review of collateral and promotional material to ensure alignment of messaging and claims to regulatory compliance, scientific accuracy, and clinical evidence. 

What you need  

Basic Qualifications:

• Bachelor’s degree, preferably with Health Sciences or related technical field. 
• 6+ years of relevant clinical research experience, preferred in clinical study management.

Preferred Qualifications:

• Medical device experience. 
• Advanced degree (MSc, PhD) in health sciences, biomedical engineering, health outcomes research.
• Preferred clinical research or project management certification

$100,500.00 - $215,300.00 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.

This role will be posted for a minimum of 3 days.