Technology Specialist

2 weeks ago


Hyderabad, India Imaging Endpoints Full time

SUMMARY 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 (SMIURadPartners), the largest private radiology group in the United States. We are recognized as the world's largest and most preeminent iCRO in oncology. Under the direction of Imaging Operations Management this position is responsible for conducting a variety of QC/analysis procedures and performing read assignment as per study-specific procedures. This person is responsible for reviewing the imaging data received from clinical trial imaging sites/sponsors to confirm specific protocol requirements have been met as well as ensuring technical adequacy and data integrity. In addition, this person will assist in project management duties within the operations department and serve as imaging technical support for internal and external staff. CLINICAL TRIAL IMAGING SPECIALIST Perform technical quality review of images per trial specifications Perform Quantitative image analysis Perform imaging data reconciliation per trial specifications Manage research projects and early phase clinical trials for day-day activities Complete quality control documentation according to standard operating procedures Develop quality control documentation in conjunction with the Project Manager Track the read assignment status and additional information in Clinical Trial Management Systems (CTMS) Clinical site and imaging center support Develop training materials for imaging site personnel Perform technical training of imaging site personnel (on-site or telecon) Assist in the writing of site imaging manuals Assist in the training of internal staff EDUCATION AND EXPERIENCE: Bachelor's degree in a science or health related field or Registered Technologist (R.with advance modality experience in CT, MRI or Nuclear Medicine preferred. Proficiency in MS Office and internet applications required Minimum of 2 years of experience in medical imaging required Minimum of 1 year of experience in the clinical trials industry preferred Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is preferred Image Review Charter, Imaging Manual, Data Transmittal Forms, etc. CLINICAL TRIAL IMAGING SPECIALIST II Perform technical quality review of images per trial specifications Perform Quantitative image analysis Perform the project trainings for new team members and site trainings Track the read assignment status and additional information in Clinical Trial Management Systems (CTMS) Creation and/or review of image QC checklists, imaging manuals, site evaluation questionnaires, training material for imaging site personnel, and any other site required documents Perform technical training of imaging site personnel (on-site or telecon) Perform AG Mednet user acceptance testing (UAT) and documentation for new studies and enhancement for existing studies to confirm correct study set up EDUCATION AND EXPERIENCE Bachelor's degree in a science or health related field or Registered Technologist (R.with advance modality experience in CT, MRI or Nuclear Medicine preferred Proficiency in MS Office and internet applications required Minimum of 3 years of experience in medical imaging required Minimum of 2 years of experience in the clinical trials industry preferred Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is preferred Knowledge of the drug development process and clinical trials process and/or experience working in a pharmaceutical environment preferred Image Review Charter, Imaging Manual, Data Transmittal Forms, etc. Proficiency in MS Office and internet applications Service-oriented approach, flexible, and proactive toward adapting to client needs Ability to manage project activities with diverse group and individuals with little supervision Self-driven, ability to get the job done with little supervision, can-do positive attitude Ability to excel in a team environment Maintain strict confidentiality of sensitive data, records, files, conversations, etc. 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: 5 to 10% (domestic and/or international)



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