GE HealthCare Clinical Project Manager 

United States, Wisconsin 

115588381

Roles and Responsibilities

• Project manages defined research activity, which may include, internal and external, GEHC and Investigator Sponsored studies, product evaluations, reader studies and other activities defined to meet strategic research needs.
• Ensures that the research activities abide by all defined cross-functional standards, meets the intent and letter of Phased Review Discipline, QMS, SOPs, GCP, and all compliance and regulatory requirements of the applicable regions.
• Leads the cross-functional research activity team and project manages the activity to conduct assigned internal and external research activity and deliver the required deliverables per the business needs and defined study plan.
• Partners with the Govt funded project teams for prioritization and changes to study details.
• Develops research documents as required, including protocols, plans, informed consent forms, and required storage of research documents including managing.
• Conducts and/or coordinates required training, initiation, monitoring and closure with study site and study team. Serves as QC to support review and approval of these activities for peer studies as required.
• Maintains applicable study records in a timely and accurate fashion which may include Clinical Trials Management System, MyWorkshop, regional regulatory records (e.g. ClinicalTrials.gov), Support Central, and/or other study records.

Required Qualifications

• Bachelor’s Degree in life science, engineering, clinical field or equivalent
• 5+ years of progressive experience
• Clinical Trial and Project Management industry experience
• CRO or industry MedTech company experience
• Demonstrated and progressive responsibility and experience project managing clinical and/or technical research and development studies in a clinical setting, industry, or government agency or similar projectmanagement/compliance/quality
• Demonstrated understanding and experience with Good Clinical Practices, global and regional research or device regulations
• Demonstrated ability to build lasting cross-functional relationships in a global setting

Desired Characteristics

• Master’s Degree in science or related field or advance medical degree
• Professional certification in Project Management (PMP) or clinical research (CCRP, CCRA, or CCRN)