Job Description Ensure image quality review and GCP compliance of clinical studies and business requests during image data handling. Provide input based on experience to develop clinical study imaging manuals. Develops or leads scientific and/or technical and/or operational design activities using existing and/or inventing new scientific, technological and/or operational approaches and methods. Travel to clinical study sites to assist with or perform their initiation and training. In certain cases, the site training may need to be performed remotely (i.e., via telephone, web conference, or similar) with equivalent efficacy. Complete image review and give written/verbal feedback to clinical sites to ensure adequate image quality and protocol compliance during clinical studies. Oversee imaging- related aspects of clinical studies when third-party vendors are involved to ensure compliance and quality. Maintenance, training and support of the computerized image systems in cooperation with the image data specialist(s). (System-specific training will be provided.) Developing effective working relationships with stakeholders to fulfill the needs of the clinical study. This may include internal staff and personnel at participating clinical sites. Proposes and drives new initiatives in relevant areas that potentially have high business impact (e.g., process improvement), based on thorough understanding of unmet needs. Leads internal ITG operational projects, including planning and stakeholder management. Mentors junior staff and certifies the competence of new staff within specific areas of expertise. Has responsibility for the oversight of ITG quality documentation and plans and/or leads document management review processes. Provides troubleshooting help for new or existing members of ITG Maintenance, training, and support of computerized image systems in cooperation with the image data specialist(s). (System-specific training will be provided.) With a LEAN Mindset participate in continuous improvement activities by identifying and appropriately escalating process and product quality gaps, providing solutions when possible. Perform project specific tasks in compliance with Good Clinical Practices (GCP), regulatory requirements (21CFR Part 11, GDPR, HIPAA, etc.), applicable departmental and enterprise-wide SOPs and project specific protocols Qualifications/Requirements: BSc or MSc in in Physics, Nuclear Medicine, Radiography, or related field. Minimum 5 years work experience in either Molecular Imaging, Radiography or Diagnostic Radiology with proven knowledge in more than one imaging modalities (e.g PET/CT, SPECT, CT, MRI). In depth expertise and hands on experience in scanner qualification (phantom imaging and analysis) and image QC. Knowledge in the scientific and clinical research of diagnostic imaging agents. A high degree of initiative and the ability to work systematically and independently is expected. Ability to persevere and work effectively during high-stress situations with strict attention to detail. Experience with Digital Imaging and Communications in Medicine (DICOM). Experience identifying, troubleshooting, documenting and following technical problems through to completion. Experience in using medical imaging workstations Experience with writing clinical study manuals (e.g. imaging manual or image acquisition protocol or quality control manual). Excellent communication and interpersonal skills and ability to work in a team. Desired Characteristics: Relevant professional qualifications and certifications (e.g., State Registration as a Clinical Scientist or Board Certification, Member or Fellow in an appropriate professional body, licensed technologist or radiographer). Prior experience working at an imaging core lab or similar environment relating to multi-site clinical trials. Experience and relevant work with dosimetry. Experience creating and editing Standard Operating Procedure’s (SOPs). Experience with blinded reads and direct contact with clinical trial sites. Able to establish good and productive relationships with cross functional and cross business groups02 involve/motivate others to work toward team objectives. Inclusion and Diversity GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, ***, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
