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.
The Product Manager (Imaging Platform) will be responsible for managing end-to-end implementation of cloud-based, integrated imaging data platforms used within clinical trials. The role requires strong project management skills and experience with software applications, particularly platforms that support imaging data centralization, workflow automation, data integration, and end-to-end visibility across clinical trial sites, sponsors, and core labs.
PRODUCT MANAGER (IMAGING PLATFORM)
RESPONSIBILITIES
Lead the implementation, configuration, and customization of imaging trial management platforms, ensuring they meet project-specific requirements as it relates to imaging clinical trials.Collaborate with cross-functional teams including Operations, Data Management, IT, and external vendors to ensure successful deployment and adoption.Develop and manage project plans, timelines, and budgets for platform implementation projects.Serve as a subject matter expert on platform workflows, including imaging trial management, workflows, quality checks, and data reconciliation.Coordinate with vendors and technical support teams to troubleshoot issues, optimize system performance, and implement updates.Implement necessary processes, procedures and train end-users to provide ongoing support.Gather user feedback and identify opportunities for platform/process improvements and automation.Maintain comprehensive documentation related to project scope, configurations, validation, and user requirements.Keep abreast of updates and best practices related to the platform and related clinical trial technologies.EDUCATION AND EXPERIENCE
Bachelor's degree in Life Sciences, Computer Science, Engineering, or related field; Master's degree preferred.5+ years' experience within iCRO industry.3+ years prior project management experience.Proven experience in implementing and managing clinical trial software platforms, with a focus on imaging data and workflows.Experience working with platforms similar to Medidata Rave Imaging or other integrated clinical data management systems.Excellent communication, stakeholder management, and cross-functional collaboration skills.Knowledge of clinical trial processes, regulatory standards, and data management practices.Ability to work independently and in a team environment within a fast-paced setting.Certifications in project management (PMP, Agile, etc.) are a plus.SKILLS
Superior attention to detail, particularly in written documentationService oriented approach, flexible, and proactiveSelf-driven, ability to get the job done with little supervision, can-do positive attitudeAbility to excel in a team environmentAbility to work in strict compliance with all procedures, rules, and regulationsAbility to manage projects and deliverables with a high level of accuracy and completeness.Maintain strict confidentiality of sensitive data, records, files, conversations, etc.Must be self-motivated and able to grasp new concepts quicklyExcellent hands-on computer skills with thorough knowledge of Microsoft Office to include Word, Excel and Power Point.IMAGING ENDPOINTS' TEAM CHARACTERISTICS
Passion to Connect Imaging to the CureTM and pursue a meaningful career by improving the lives of cancer patients through imagingStrong 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 imagingCommitment and caring for our fellow team members, their families, and the communities IE serves - see Caring Endpoints Integrity and high ethical standards; we always do the right thingHigh intellect and ingenuity; we enjoy solving problems, finding a better way, and the challenge of making a difference by improving livesStructured, 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 everydayAccountable; we do what we say and communicative effectively to meet deadlines; we enjoy advancing clinical trials, helping patients, and celebrating successHigh standard for excellence; we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all elsePHYSICAL 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.
Read LessImaging 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.
The QMS Specialist is primarily responsible for assisting QMS Leadership in executing day-to-day tasks associated with managing, maintaining, and continually improving the Imaging Endpoints Quality Management System. The QMS Specialist is a compliance and solutions-oriented individual who plays a key role in achieving business and stakeholder needs with respect to quality assurance principles and practices.
QMS SPECIALIST
RESPONSIBILITIES
Provide quality system management assistance within the regulations of investigational products and quality standards, specifically: 21 CFR Part 312, 21 CFR Part 211, and ISO 13485.Provide direct QA support related to Imaging Endpoints training programs, nonconformance management (deviation program and CAPA program), QMS auditing programs (internal audits, external audits), and vendor management programs.Manage and maintain the IE audit programs, including scheduling, coordination, and performance of both internal and vendor audits.Manage and maintain the IE vendor qualification and management program.Conduct routine Vendor qualification file audits to trigger required updates and performance of specified vendor maintenance activities (e.g., file updates, vendor audits, etc.).QA responsibilities include, but are not limited to, GxP documentation creation, editing, and/or review for procedures related to the QMS.Responsible for creating and fostering mutually beneficial intradepartmental, cross-functional, and organizational relationships to drive compliance to specified program objectives.Interface with Compliance and Regulatory Affairs Management to implement quality system strategies and plans which facilitate continuous QMS improvement.Interface with other areas of the organization to provide sound decision-making in areas that impact the QMS and/or IE compliance to regulations and guidance documents.Assist the QMS Management in the management, maintenance, and reporting of IE CAPA and Deviation systems, including discrepancy investigation and reporting, as well as tracking and trending activities.Assist Compliance and Regulatory Affairs Management during Internal Audits, Sponsor Audits, or Regulatory Inspections, including the effective preparation of related documentation, training of staff, providing accurate information and tracking of audit responses.Assist the QMS Director/Management in establishing and reporting applicable quality metrics.Ensure proper control, retention, and archival of QMS documentation.Assist in establishing, implementing, and maintaining QA procedures and controls to develop a compliant IE QMS.Perform other duties as assigned by Compliance and Regulatory Affairs Management. Act in a supporting role to other QMS positions.EDUCATION AND EXPERIENCE
Bachelor's degree in pharmaceutical sciences or other related scientific disciplines.Minimum three (3) years of experience in a regulated industry with at least two (2) years of experience in pharmaceuticals and/or medical device.QMS experience.QMS auditor certification preferred (e.g., CQA).Imaging Core Lab and/or Contract Research Organization experience preferred.Knowledge and understanding of 21CFR Part 211, 21CFR Part 312, ISO13485, and Good Clinical Practices (ICH E6 GCP), Good Documentation Practices (GDP), and Good Manufacturing Practices (GMPs).Good working knowledge of CAPA / deviation processes, investigational methodologies, and procedures.Good working knowledge of audit practices, strategies, and principles.Proficiency in MS Office and internet applications.SKILLS
Work precisely and in compliance with all procedures, rules, and regulations.Must maintain strict confidentiality of sensitive data, records, files, conversations, etc.Excellent interpersonal, organizational and communication skills, including oral and written.Self-motivated and able to grasp new concepts and learn quickly.Ability to motivate others and facilitate a positive work environment.Ability to manage projects and deliverables with a high level of accuracy and completeness.Ability to work independently with minimal supervision.Excellent hands-on computer skills with thorough knowledge of Microsoft Office to include Word, Excel, and Power Point.IMAGING ENDPOINTS' TEAM CHARACTERISTICS
Passion to Connect Imaging to the CureTM and pursue a meaningful career by improving the lives of cancer patients through imagingStrong 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 Integrity and high ethical standards; we always do the right thingHigh intellect and ingenuity; we enjoy solving problems, finding a better way, and the challenge of making a difference by improving livesStructured, 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 everydayAccountable; we do what we say and communicative effectively to meet deadlines; we enjoy advancing clinical trials, helping patients, and celebrating successHigh standard for excellence; we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all elsePHYSICAL 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: Estimated up to 10% travel (domestic and international)
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