ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
As a Vendor Start Up Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
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
Work Experience:
- 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
Why ICON?
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
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