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Imaging Project Manager
1 month ago
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
What you will be doing: Functional imaging operations lead for assigned clinical trials interacting with multi-disciplinary internal and external teams. Responsible for imaging operations including, implementation of standardized imaging procedures, day to day operational activities, monitoring imaging KPIs and imaging workflow to ensure timelines and deliverables are achieved. Job Description:- Supports the development and approval of vendor-generated documents including Imaging Review Charters, Site Imaging Manuals and Project Plans. Provide guidance and seek input from internal stakeholders including medical, biostatistics, clinical science, study management and data management to ensure alignment and implementation of best practices.
- Serve as the point of escalation for study teams to facilitate solutions for imaging related issues.
- Guide collaboration between the study team, site staff and the imaging vendor, providing scientific and operational input on collection, analysis, and reporting of efficacy data based on the imaging assessments.
- Oversee Imaging operations performance and quality metrics at a study level; identify trends/gaps within the processes. Ensures adherence to defined scope of work, high quality standards, and best practices.
- Supports team in achieving imaging milestones and deliverables.
- Ensures strong inspection readiness for all imaging related content/activities for assigned clinical trials. Supports study teams with imaging related audit responses, quality issues, CAPAs and regulatory inspections.
- Supports development of EDC systems and eCRF technical requirements as it relates to CRO and imaging vendor data tracking, analysis systems and exports.
- Supports the development of Imaging Operations trainings and guidance documents. Provides imaging trainings for the study team and site staff as needed.
- Supports the development and implementation of continuous imaging process improvement initiatives.
Job requirements:
- Bachelor’s Degree in Life Sciences or Healthcare Preferred
- Minimum 3 years of imaging operations experience supporting clinical drug development in an industry setting.
- Fluency in English
- Experience working with or for an imaging CRO in support of late-stage clinical trials. Oncology is strongly preferred.
- Knowledge of multiple imaging modalities and their application to drug development.
- Imaging data collection, quality control, review, and analysis
- GCP/ICH guidelines
- Excellent communication skills, both verbal and in writing
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
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