Global Project 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 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 the Operations staff, Sponsor staff, and study sites in coordinating clinical project activities. The Global Project Specialist/Global Project Specialist II requires skill similar to an Associate Project Manager.

GLOBAL PROJECT SPECIALIST

RESPONSIBILITIES
Provide day-to-day oversight and support in conjunction with Project Managers (PM) in the planning and execution of imaging clinical trials by proactively monitoring study progress, milestones, risks, project timelines, work plans, trackers, and turnaround times.
Support and oversee study start-up, conduct, and close-out activities by ensuring readiness, completeness, and quality of required documentation.
Lead the preparation, review, and finalization of internal and external Kick-Off meeting materials, site start-up communications, Study Start-Up, Vendor, and Close-out checklists.
Assist the PM with hosting the external sponsor meetings. Independently draft, coordinate, and distribute internal and external meeting agendas and minutes; actively drive action item completion, follow-ups, and accountability across stakeholders.
Prepare, analyze, and deliver high-quality project status updates, metrics, dashboards, and reports to internal teams and external sponsors, highlighting trends, risks, and operational insights.
Serve as a primary operational point of contact for Clinical Project Coordinators (CPC), providing guidance and oversight on imaging site activities including site communications, evaluations, training coordination, and query resolution.
Provide oversight and subject-matter expertise to CPCs in maintaining the electronic Trial
Master File (eTMF), ensuring ongoing accuracy, completeness, and inspection readiness. Lead and/or oversee eTMF QC and reconciliation activities, including ongoing QC and study close-out tasks.
Support audits and inspections by coordinating the collection and review of objective evidence as well as supporting deviation management and CAPA documentation.
Maintain and oversee study data and systems, including study reporting, metrics tracking and reader dossier preparation, ensuring data quality and consistency across systems.
Review and support billing activities, including monthly billing and forecasting, routine overbilling reconciliation, and study close-out reconciliation, identifying discrepancies and ensuring timely resolution.
Support PMs with ongoing deliverables and real-time reporting. Independently manage assigned project activities, exercising sound judgment and decision-making.
Serve as a…