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 equivalent5+ years of progressive experienceClinical 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 project management/compliance/quality role in a medical device or pharmaceutical company.Demonstrated understanding and experience with Good Clinical Practices, global and regional research or device regulationsDemonstrated ability to build lasting cross-functional relationships in a global settingDesired Characteristics
Master’s Degree in science or related field or advance medical degreeProfessional certification in Project Management (PMP) or clinical research (CCRP, CCRA, or CCRN)Additional InformationGE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No