Job Description Summary As a Clinical Research Assistant - Blinded Image Evaluation Manager, you will support the development of new imaging agents (or Investigational Medicinal Products) throughout the development phases in accordance with IHC-GCP and Standard Operating Procedures (SOPs)

This is achieved by the receipt, processing, preparation for image data for assessment and archiving of clinical trial images from a range of modalities within the GE Healthcare Pharmaceutical Diagnostics portfolio. This role is responsible for the Planning, Initiating and Conduct of Blinded Image Evaluations (BIE). A BIE is the industry practice of collecting all clinical study images as defined by the Clinical Study Protocol and the Imaging Manual acquired at investigative sites and presenting this data to a separate group of Independent Blinded Readers for evaluation. Evaluating efficacy of diagnostic agents, therapeutic drugs, or medical devices in accordance with FDA, EMA.

The role is based in the Imaging Technology Group and reports to the Global Head of Imaging Technology and is based in the GE Healthcare office in Amersham, United Kingdom.

Job Description Responsibilities

• Project manage, prepare and oversee onsite and remote Blinded Image Evaluation (BIE) preparation related processes including applicable paperwork and close out activities
  
• Willing to travel to GE specific identified locations within the UK and outside of the UK depending on the location of the BIE.
  
• Provide input to the Electronic Data Capture system development related to the BIE electronic case report form, by completing the User Acceptance Testing (UAT) and providing feedback to the Imaging Technology Leader
  
• Identify BIE Monitors to support with the BIE monitoring activities and conduct detailed training sessions.
  
• Work with the Imaging Technology Leaders, Medical Imaging Scientist, Statisticians and Data Managers as well as external vendors to ensure timely task preparation and delivery
  
• Blind and Randomize the image data using automated software or manual processes
  
• Contribute, author and/or prepare the development of BIE related documentation
  
• Ensure that all evidence and BIE related documentation are collected and archived in a timely manner in the internal Electronic Trial Master File to ensure audit reediness
  
• Ensure Good Clinical Practice (GCP) Compliance throughout the processes and data blinding.
  

Qualifications and experience

• Clinically trained in a related field (e.g Clinical Research Assistant, Diagnostic Radiography) or a related degree i.e. BSc in Biomedical Engineering, Medical Imaging or Medical Physics Experience with Digital Imaging and Communications in Medicine (DICOM)
  
• Experience identifying, troubleshooting, documenting, and following technical problems through to completion
  
• An interest in clinical research, clinical trials, and willingness to learn new processes Experience with project management
  
• Experience with project management (e.g Microsoft Project, Smartsheets) and Microsoft Windows tools (e.g excel, word etc.)
  
• 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
  

Desirable skills

• Previous experience with handling clinical data and data management
  
• Previous experience with clinical trials, coordination of research activities or diagnostic imaging procedures in a healthcare setting or a clinical research organization
  
• Competency in using medical imaging workstations
  
• Good experience with at least one imaging modalities e.g. X-ray, CT, MRI, Ultrasound or Nuclear Medicine
  
• The ability to establish good and productive relationships with cross functional and cross business groups; involve/motivate others to work toward team objectives
  

Eligibility requirements
A good level of English and a valid work permit

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, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

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.

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Additional Information Relocation Assistance Provided: No