Associate Clinical Study Manager (Hybrid)

Stryker 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 all 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, pre-approval, post-approval, post-market surveillance, feasibility, and/or investigator managed studies. This position contributes to the Clinical Research team activities for designated projects and ensures patient safety, quality and integrity of data, compliance with relevant SOPs and regulatory requirements and completes studies on-time and on-budget.

What you will do

• Contribute to trial synopsis, protocol, and amendments to ensure operational feasibility; contribute to defining the Case Report Form content; develop study-specific procedures, 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 proper collection and validation of data and documentation in a timely manner.
• Communicate to teams regarding monitoring activities, data flow, and data validation / cleaning; perform patient data validation homogeneously and fulfill required quality standard; 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 timely 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. 
• Liaises externally with Principal Investigators, research coordinators and research institutions. 
• Process including collection, dissemination, review, approval, notification, contracting, funding, and progress reports.

• Author/provide input into clinical regulatory activities such as CER, PMCF, etc.

What you need

Required

• Bachelor's degree in science or health care field

• 2+ years of relevant clinical research experience

Preferred

• Advanced degree (Master's or PhD)

• Demonstrated understanding of laws, regulations, standards, and guidance governing the conduct of clinical studies, as well as preparation of clinical documentation in support of regulatory submissions

• Strong organizational and project management skills

$88,800.00 - $142,300.00 USD salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.