Senior Imaging Project Leader - Global Trial Management

SUMMARY

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 Honor Health, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIL/Rad Partners), 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/Project Management Leadership this position is responsible to work with sponsors to manage timelines, deliverables, and resources, liaise with the appropriate staff to complete work as detailed in the client's contract and/or work order, and to effectively communicate project status and escalating issues with all internal and external stakeholders.

• Create and execute project work plans and revise as appropriate to meet changing needs and requirements
• Identifies resources needed and assigns individual responsibilities
• Manages day-to-day operational aspects of a project
• Review deliverables prepared by team before passing to client
• Track clinical trial projects, schedule site trainings, and maintain study details, questionnaires, logs, and checklists
• Set up the clinical trial start-up and close-out procedures
• Maintain TMF and ensure project documents are complete, current, and stored appropriately
• Prepare project status to client and management; generate weekly status, site, and enrollment reports
• Complete quality control documentation according to standard operating procedures
• Assist in the development of study documentation and perform quality controls
• Perform CTIS function to quality review the project images as needed
• Review and approve training materials for imaging site personnel
• Review and approve the site evaluation documentation
• Project manage early phase clinical trials
• Assist a tenured Project Manager with registration clinical trials
• Mentor and assist in the training of project associates
• Perform other duties as assigned by supervisor

• Bachelor's degree in a science or health-related field (or equivalent combination of education and professional experience)
• Minimum of 2 years industry (clinical CRO or pharmaceutical industry) experience is required
• Minimum of 2 years in medical imaging preferred
• Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is required
• Exposure to electronic data capture for clinical trials required

• Execute project deliverables for imaging studies in clinical trials in accordance with project scope of work and within sponsor specified timelines;
• Manage day-to-day operational aspects of a clinical imaging projects;
• Assist in preparation and adherence to imaging trial documents i.e. Image Review Charter, Imaging Manual, Data Transmittal Forms, etc;
• Ensure project documents are complete, current, and stored appropriately;
• Manage key project documents/processes, i.e. Project Management Plan, Communication Plan, Escalation Plan, Risk Management Plan and appropriate Clinical Trial Management System (CTMS);
• Identify resources needed and assign individual responsibilities;
• Identify out of scope requests and work with appropriate team(s) to revise the work order to meet changing needs and requirements;
• Review and manage all deliverables;
• Prepare metrics reporting for client and senior management;
• Prepare forecasting information for Finance purposes;
• Perform other duties as assigned by the Supervisor

• Bachelor's degree or equivalent certification in a health related field
• Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trials setting is required
• Knowledge of key project management documents and tools a must
• Prior experience with different EDC systems required
• Proficiency in MS Office and internet applications required
• Minimum of 3 to 5 years of experience in the clinical trials industry required
• Minimum of 2 years of experience in medical imaging in a clinical trial environment required
• Experience managing global Phase III clinical trials with imaging components strongly preferred
• PMP certification a plus

• Execute…