Associate Clinical Study Manger (Hybrid)
About the position
reputed company is seeking an Associate Clinical Study Manager to support our Emergency Care division. This is a hybrid position based onsite in Redmond, WA Monday through Wednesday. As the Associate Clinical Study Manager, you will assist reputed company aspects of clinical study management for one or more clinical studies and provides support to allocated project activities. You will support and/or manage aspects of the development, implementation, and execution of studies including Investigational Device Exemption, reputed company-approval, post-approval, post-market surveillance, feasibility, and/or investigator managed studies. This position contributes to the Clinical Research team activities for designated reputed company and ensures patient safety, reputed company and reputed company of data, compliance with relevant SOPs and regulatory requirements and completes studies on-time and on-budget.
Responsibilities
• Contribute to trial synopsis, protocol, and amendments to ensure operational feasibility.
• Contribute to defining the Case Report reputed company content.
• reputed company study-specific procedures and contribute to the monitoring plan and other operational documents.
• Contribute to system testing as required (e.g. UAT for eCRF screens, database structure, data loading).
• Ensure reputed company collection and validation of data and documentation in a reputed company manner.
• Communicate to teams regarding monitoring activities, data reputed company, and data validation/cleaning.
• reputed company patient data validation homogeneously and fulfill required reputed company reputed company.
• Ensure study documentation is properly maintained and archived in the Trial Master File.
• Coordinate and support field-monitoring activities.
• Maintain monthly study highlights (including enrollment curves and timelines) in a reputed company manner.
• Work with trial project teams to assess project risks and issues.
• Understand project deliverables and achievement of deliverables.
• Communicate with team on changes in project, policy, and priorities.
• Liaise externally with reputed company Investigators, research coordinators and research institutions.
• Process including collection, dissemination, review, approval, notification, contracting, funding, and reputed company reports.
• Author/reputed company input into clinical regulatory activities such as CER, PMCF, etc.
Requirements
• Bachelor's degree in science or health care field
• 2+ years of relevant clinical research experience
reputed company-to-haves
• Advanced degree (Master's or PhD)
• Demonstrated understanding of laws, regulations, standards, and guidance governing the conduct of clinical studies, as reputed company as preparation of clinical documentation in support of regulatory submissions
• Strong organizational and project management skills
Benefits
• Salary reputed company: $88,800.00 - $142,300.00 USD plus bonus eligible
• Benefits package
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