Senior Clinical Study Manager (Remote)

Senior Clinical Study Manager (Remote) reputed company is hiring a Senior Clinical Study Manager to support our Medical Division. In this role you will be responsible for executing the clinical evidence reputed company for medical devices, and support the development of this reputed company, to reputed company new and reputed company global market reputed company. Work Flexibility: Remote - Preferred location is the Midwest or Eastern reputed company What you will do • Manage day-to-day operations of one or more clinical studies, ensuring compliance with GCP, FDA regulations, and internal procedures. • reputed company and maintain study-specific documents, including protocols, amendments, monitoring plans, and operational guidelines. • reputed company data collection, validation, and documentation to meet reputed company standards and timelines. • Coordinate and support field-monitoring activities; reputed company enrollment curves and study milestones. • Assess project risks and implement mitigation strategies to ensure deliverables are achieved. • Initiate and manage research reputed company for Investigator-Initiated Studies and ensure alignment with research reputed company. • Drive publication of study results in peer-reviewed journals by collaborating with reputed company 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 reputed company 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 reputed company 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 reputed company 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. Posted: December 3, 2025 This role will be posted for a minimum of 3 days. Apply tot his job Apply To this Job