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Sr. Clinical Research Program Manager- Ultrasound

2 months ago

Wauwatosa, United States GE Healthcare Technologies Inc. Full time

Job Description Summary

We are seeking a Senior Clinical Research Program Manager (Sr Research Program Integrator- RPI) who is passionate about clinical research and project management. The RPI will work with cross functional clinical research and product development teams as well as external Institutions and Investigators in support of the government funded projects for the Ultrasound businesses within GE Healthcare. The Sr RPI will provide leadership and execution for the Sponsored Clinical Trials within the government funded projects which includes planning, study development and execution, communication on research activity.

Job Description

Roles and Responsibilities

* Partners closely with GEHC Healthcare Technology Innovation Center to manage clinical research under government funded projects.
* Project manages defined research activity, which includes, internal and external, GE 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.
* Advises on appropriate path for each research study by addressing the requirements and tradeoffs of different processes, especially from a Quality and Regulatory standpoint.
* 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.
* Develops research documents as required, including protocols, plans, informed consent forms, and required storage of research documents including managing Trial Master Files.
* Negotiates budget and contracts with external partners and processes payments.
* 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.
* Develops relationships with and supports external research partners and manages communication with external sites in a professional and productive manner.
* Serves as a leader within the Ultrasound Research team.

Required Qualifications

* Bachelor's Degree in life science, engineering, clinical field or equivalent
* 7+ years progressive responsibility and experience in managing clinical trials including industry sponsored clinical trials
* Demonstrated understanding and experience with Good Clinical Practices, global and regional research or device regulations
* Demonstrated ability to build lasting relationships within a matrix organization and to work flexibly with global teams
* Excellent written and verbal communication skills.
* Demonstrated clear thinking and problem-solving abilities, a creative mindset, and the ability to quickly grasp new ideas.
* Self-starter, able to work independently and collaboratively, results oriented, able to multi-task.

Desired Characteristics

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

Additional Information

GE 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

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