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Imaging Analyst
| Company | Exelixis |
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| Location | Alameda, CA, USA |
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| Salary | $84500 – $120500 |
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| Type | Full-Time |
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| Degrees | Bachelor’s, Master’s |
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| Experience Level | Mid Level |
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Requirements
- BS/BA degree in related discipline and a minimum of three years of related experience; or, MS/MA degree in related discipline and a minimum of one year of related experience; or, an equivalent combination of education and experience.
- Sound knowledge of Good Clinical Practice and FDA regulations.
- Familiarity with the clinical trials process and/or experience working in an Imaging Core Lab and ECG (Suppliers) environment is preferred.
- Familiar with Interactive Response Technologies, including design, testing, deployment, user management, and report generation.
- Working knowledge of clinical trial databases (e.g. EDC, CTMS).
- Ability to work in a fast-paced environment.
- Strong organization and communication skills.
- Excellent attention to detail and orientation toward meticulous work.
- Proficient in Excel, Word, PowerPoint, and Visio.
Responsibilities
- Liaise with internal stakeholders on troubleshooting systems and operational issues (e.g., maintenance, functionality user access) as needed.
- Assist in the oversight and management of technology supplier(s).
- Collect, track and analyze technology supplier(s) performance metrics.
- Read and understand project protocol documents. Participating in project meetings, conference calls, and training calls.
- Review status report(s) and query report(s), identify issue trends and provide updates to study teams.
- Monitor cross-study technical and operational issues and manage escalated issues to resolution.
- Assist in imaging protocol deviation surveillance oversight and provide regular updates to internal stakeholders.
- Ensure the Data Protection Act is applied to all subject data and that subject confidentiality is maintained at all times.
- Support and coordinate study site start-up activities with Clinical Operations and technology suppliers (e.g. IxRS, Imaging, eCOA, ECG).
- Manage communication between study teams, internal stakeholders, and the supplier(s).
- Execute and document results of test scenarios for user acceptance test (UAT).
- Assist with CRO and Clinical Technology Suppliers in monitoring and resolving data discrepancies.
- Provide support to the Senior Team Members on study-related duties during Pre and Post Post Production site enablement activities.
- Assist with identifying metrics and solutions for trend analysis of potential and current issues.
- Support records retention management.
Preferred Qualifications
- Experience in biotech/pharmaceutical industry is preferred.
- Experience in Clinical Operations, Imaging Core Lab, or IxRS supplier experience is a plus.
- Experience in radiographic imaging in a clinical environment is a plus.
- Experience in RECIST 1.1 is a plus.
