Manager overseeing Project Management team in Clinical Research at Sanford Health. Collaborating with Clinical Research Managers and guiding strategic research initiatives.
About the role
- Senior Clinical Study Manager supporting Medical Division with clinical studies to enable market access for medical devices. Ensuring compliance and overseeing operations for clinical evidence gathering.
Responsibilities
- 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
Job title
Job type
Experience level
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Degree requirement
Tech skills
Location requirements
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