Principal Medical Applications Services Specialist

Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the CureTM. Everything we do is aligned with this singular purpose. 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.

Imaging Endpoints is based in Scottsdale, Arizona, with offices in Cambridge, Massachusetts; London, UK; Leiden, Netherlands; Basel, Switzerland; Hyderabad, India and Shanghai, China. 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

RESPONSIBILITIES

1. Participate in the development and/or review of application development deliverables for imaging studies in clinical trials. Specifically:

• Read and understand sponsor-specific Scope of Work (SoW) and clinical study protocols
• Read and understand imaging review charters (IRC)
• Analyze and understand assessment criteria guidelines

2. 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

3. 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.

4. Utilize tools such as Workflow/Application Wireframes in support of new studies as needed.

5. Secondary activities include:

• 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.

6. Perform other duties as assigned by the supervisor

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

SKILLS

• Self-motivated and able to grasp new concepts quickly
• Work precisely according to all procedures, rules, and regulations
• Must have superior attention to detail and excellent oral and written communication skills
• Hands-on ability to think tactically and strategically
• Service oriented approach, flexible and proactive towards adapting to clients' needs
• Ability to excel in a team environment.
• Must have the ability to work under pressure.
• Must have strong time management, and organizational skills. Prioritizing workload according to the changing needs of the day-to-day business is critical.
• Must maintain strict confidentiality of sensitive data, records, files, conversations, etc.
• Proficiency in MS Office and internet applications

IMAGING ENDPOINTS’ TEAM CHARACTERISTICS

• Passion to Connect Imaging to the CureTM and pursue a meaningful career by improving the lives of cancer patients through imaging
• 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 https://caringendpoints.org/
• Integrity and high ethical standards; we always do the right thing
• High intellect and ingenuity; we enjoy solving problems, finding a better way, and the challenge of making a difference by improving lives
• Structured, organized, detail-oriented, and self-motivated; we approach each day with a detailed plan and excitement to accomplish the day’s objectives while striving to improve ourselves and IE everyday
• Accountable; we do what we say and communicative effectively to meet deadlines; we enjoy advancing clinical trials, helping patients, and celebrating success
• High standard for excellence; we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all else

PHYSICAL REQUIREMENTS

While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.

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