GE HealthCare Senior Clinical Program Manager AVS 

Remote, Remote 

845448767

Job Description Summary

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).