Imaging Endpoints
Website:
imagingendpoints.com
Job details:
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.
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 reliable back-up for the PM and/or CPCs during their absence, assuming operational ownership to ensure continuity of project execution and effective communication with internal and external stakeholders.
- Ensure consistent compliance with protocols, SOPs, regulatory requirements, HIPAA, and data protection standards; proactively identify compliance risks and support corrective actions.
- Perform other duties as assigned by supervisor.
EDUCATION AND EXPERIENCE
- Bachelor’s degree in a science or health-related field is required.
- Minimum of 2 years of relevant experience in a project support role is required.
- Minimum of 2 years industry experience is required (clinical CRO or pharmaceutical industry).
- 2+ years experience in medical imaging within clinical trial environment preferred.
- Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trial setting is required.
- Knowledge of key project management terminology and tools is preferred.
GLOBAL PROJECT SPECIALIST II
RESPONSIBILITIES
- All responsibilities of GPS plus:
- Provide onboarding, training, and ongoing mentoring to new GPS personnel; serve as a resource for processes, systems, and best practices, and contribute to training materials and knowledge sharing initiatives.
EDUCATION AND EXPERIENCE
- Bachelor’s degree in a science or health-related field is required
- Minimum of 3 years of relevant experience in a project support role is required.
- Minimum of 3 years industry experience is required (clinical CRO or pharmaceutical industry).
- 3+ years experience in medical imaging within clinical trial environment preferred.
- Knowledge of Good Clinical Practice (GCP), Quality Assurance/Compliance in a clinical trial setting is required
- Knowledge of key project management terminology and tools is preferred.
- Experience with global Phase III clinical trials with imaging components required.
SKILLS
- Proficiency in MS Office and internet applications is required.
- Service-oriented approach, flexible, and proactive toward adapting to client needs.
- Ability to independently manage multiple projects, collaborate effectively, and meet tight deadlines.
- Must have superior attention to detail including excellent oral and written communication skills.
- Must have strong time management and organization skills.
- Ability to excel in a team environment.
- Ability to strictly adhere to all procedures, rules, and regulations while maintaining the confidentiality of sensitive data, records, files, and communications.
- Ability to prioritize workload to meet changing day-to-day business needs while effectively understanding and leading technical research activities within a research environment.
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.
Travel: 5 to 10% (domestic and/or international)
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