Senior Clinical Study Manager
Stryker
full-time
Posted on:
Location Type: Hybrid
Location: Concord • New Hampshire • 🇺🇸 United States
Visit company websiteSalary
💰 $100,500 - $215,300 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- 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.
Requirements
- Bachelor’s degree, preferably with Health Sciences or related technical field
- 6+ years of relevant clinical research experience, preferred in clinical study management
- Medical device experience
- Advanced degree (MSc, PhD) in health sciences, biomedical engineering, health outcomes research
- Preferred clinical research or project management certification
Benefits
- health insurance
- retirement plans
- paid time off
- flexible work arrangements
- professional development
- bonuses
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical study managementdata collectiondata validationregulatory compliancerisk assessmentproject managementclinical documentationpublication managementmonitoring plansoperational guidelines
Soft skills
collaborationcommunicationorganizational skillsproblem-solvingleadership
Certifications
clinical research certificationproject management certification