Clinical Data Manager

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 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 theworld’s largest and most preeminent iCRO in oncology.

The Clinical Data Manager I / Clinical Data Manager II / Senior Clinical Data Manager / Principal Clinical Data Manager’s primary responsibilities are to lead, direct, and conduct all clinical data management activities for each assigned clinical study. Other duties include coordinating with study team members, management and clients to complete work as detailed in the client’s work order; maintain audit readiness by ensuring study related documents are in the study eTMF in a timely manner; effectively communicate project status to internal and external stakeholders; and conduct clinical data management activities per relevant standard operating procedures and work instructions.

RESPONSIBILITIES

• Serve as primary clinical data management contact for assigned clinical studies, including both internal and external stakeholders
• Lead clinical data management aspects of processing radiological images received for client projects in accordance with standard operating procedures
• Create and maintain data management plans
• Lead the design and development of eCRFs to be used in the imaging analysis platform per client needs and study criteria
• Lead design and development of EDC and other databases
• Train applicable personnel to use data collection tools, as applicable
• Conduct quality control review of clinical trial data
• Conduct review of eCRFs, reports, or listings, as applicable
• Generate, track, and close queries for images, reports, eCRFs, as applicable
• Create and maintain data transfer specifications
• Conduct data / image transfers, as applicable
• Monitor radiology readers for applicable on-site reads
• Oversee generation and / or quality control review of Diagnostic and Summary Reports
• Lead applicable data analysis activities
• Lead UAT activities for data collection and transfer systems / tools, including creating UAT Plan and Test Cases
• Maintain paper and / or electronic project files in accordance with standard operating procedures
• Ensure compliance with all standard operating procedures
• Create applicable study specific procedures
• Create applicable study specific reports
• Assist with development and versioning of clinical data management standard operating procedures
• Lead generation of study specific data collection tools / databases
• Assist with training and mentoring of other clinical data management staff
• Update appropriate study team members and management with task, deliverable, and project statuses
• Create and maintain study timelines to meet data deliverables by planning accordingly
• Contribute to department and company process improvement
• Perform other tasks as needed

EDUCATION AND EXPERIENCE

SKILLS

IMAGING ENDPOINTS’ TEAM CHARACTERISTICS

PHYSICAL REQUIREMENTS

While performing the duties of this position, 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 : Estimated 5 - 10% travel (domestic and international)