Senior Clinical Program Manager, AVS

Job Description Summary

Job Description Summary

The GEHC AVS business consists of ultrasound consoles, handheld ultrasound devices, and ultrasound digital solutions across different market segments. As customers’ needs for more and consistent digital solutions continue to grow, the market for digital ultrasound solutions advances.

We are seeking a highly motivated and experienced individual to oversee all sponsored research for AVS. The ideal candidate will be responsible for mentoring and coaching the team running studies, setting expectations and standard work for sponsored studies, and directly running all IDE studies.

Job Description

• No sponsorship for this role and will sit in Wauwatosa office **

Key Responsibilities

• Provide oversight for all sponsored research projects within AVS.
• Mentor and coach the RPI team, ensuring they have the support and guidance needed to successfully run studies.
• Set clear expectations and establish standard work procedures for all sponsored studies.
• Directly manage and run all IDE studies, ensuring compliance with regulatory requirements and internal standards.
• Collaborate with Quality, Regulatory, Product leads, and Engineering teams to refine and implement research procedures to address AVS needs, starting with implementation of the investigational device evaluation procedure.
• Ensure that research activities abide by all defined cross-functional standards, including Phased Review Discipline, QMS, SOPs, GCP, and all compliance and regulatory requirements of the applicable regions.
• Develop key partnerships with 3rd party clinical research teams and enable their research with AVS devices.
• Lead monthly reviews of sponsored trials with Clinical Operations.
• Monitor and report on the progress of sponsored studies, identifying and addressing any issues that arise.

Qualifications

• Bachelor’s Degree in life science, engineering, clinical field, or equivalent.
• 8+ years of progressive responsibility and experience in project managing clinical research and development studies in a clinical setting, industry, or government agency.
• Proven track record in managing complex sponsored clinical trials, must have device experience
• Demonstrated understanding/experience with Good Clinical Practices, global and regional research regulations including FDA and MDR and ISO standards, New Product Introduction (NPI) cycle, and clinical trial design.
• Demonstrated ability to build lasting cross-functional relationships.

Desired Characteristics

• Master’s Degree in science or related field or advanced medical degree.
• Professional certification in Project Management (PMP) or clinical research (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