Principal Medical Applications Services Specialist

6 days ago


Hyderabad, India Imaging Endpoints Full time

Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We have supported many of the most impactful new drug approvals in oncology, and we are seeking the most talented individuals globally that are passionate in their desire to assist us in our mission to customize each clinical trial’s imaging to optimize the opportunity to demonstrate efficacy. We are an affiliate of HonorHealth, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIL/RadPartners), the largest private radiology group in the United States. We are recognized as the world’s largest and most preeminent iCRO in oncology. The Principal Medical Application Services Specialist will assist the Medical and Scientific Affairs department in its activities. The Principal Medical Application Services Specialist’s major responsibilities will be to perform, or assist with, development of application configuration documents to enable custom configurations of radiological read/analysis software, and to review verification documentation of such configurations. Additionally, the Principal Medical Application Services Specialist will assist with the development of other essential documents as described below. Principal Medical Applications Services Specialist Participate in the development and/or review of application development deliverables for imaging studies in clinical trials. Read and understand sponsor-specific Scope of Work (SoW) and clinical study protocols Develop trial configuration specifications that will be used to configure image analysis software for trial-specific application as required per the SoW, clinical protocol, and IRC Understand and maintain the Master Configuration Specifications for the image analysis software and integrate changing user requirements into appropriate configuration management and change control activity. Utilize tools such as Workflow/Application Wireframes in support of new studies as needed. Work with and assist in training of Medical Application Services Specialists, and Medical and Scientific Affairs staff, providing appropriate coaching, mentoring and development Assist Scientific Affairs Lead in the creation of training materials related to analysis systems and reader use of these systems Assist Compliance in verification / validation activities for instance- or trial-level application development and life cycle management activities Assist Data Management in developing export specifications based on analysis system/methods used in sponsor projects and in producing the data exports Assist Data Management in developing QC rules and training based on analysis system/methods Ensure that all project requirements are stated unambiguously, and that inconsistencies, omissions, and errors have been detected and corrected, supporting delivery of exquisite quality work product. EDUCATION AND EXPERIENCE ~ Bachelor’s degree in Life Science, Computer Science, Computer Information Systems, or specific applicable work experience (e.g., medical writing) ~ Knowledge of radiological imaging assessments criteria or knowledge of Java, JavaScript, C, ~ SQL, HTML, XML, JSON ~2+ years of imaging experience within the Pharmaceutical or CRO industry, or designing relevant computer applications, working in a software development environment Service oriented approach, flexible and proactive towards adapting to clients' needs Ability to excel in a team environment. Must maintain strict confidentiality of sensitive data, records, files, conversations, etc. Proficiency in MS Office and internet applications Strong desire to be part of a dynamic, global team working closely together and growing year after year in a rewarding environment to help humanity through imaging Commitment and caring for our fellow team members, their families, and the communities IE serves - see Caring Endpoints we enjoy advancing clinical trials, helping patients, and celebrating success we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all else Travel :



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