Posted in General Business 30+ days ago.
This job brought to you by eQuest
Location: Alameda, California
Reporting to the Associate Director of Technical Operations, the Imaging Analyst will work with a cross-functional team of internal stakeholders (Clinical Operations, Clinical Data Management, Biostatistics, and Clinical Development) and Medical Imaging Core Lab(s) to support Exelixis clinical trials.
The Imaging Analyst will support, coordinate and schedule training on standards, processes, and metrics to ensure consistent conduct of Exelixis' trials.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Support and assist the tracking the collection and submission of radiographic images from study sites to a CRO or an independent radiology committee (Imaging Core Lab).
• 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 imaging site start-up activities with Clinical Operations and Imaging Core Lab(s).
• Assist with CRO and Imaging Core Lab(s) in the monitoring and resolution of data discrepancies.
• Review Imaging Core Lab(s) image status report(s), query report(s) and identify issue trends and provide updates to study teams.
• Monitor cross-study technical and operational issues and manage escalated issues to resolution.
• Assist with identifying metrics and solution for trend analysis of potential and current issues.
• Read and understand project protocol documents. Participating in project meetings, conference calls, and training calls.
• Support records retention management including filing appropriate documentation into eTMF and Livelink.
• No direct reports.
• BS/BA degree in related discipline and three years of related experience; or,
• MS/MA degree in related discipline and one year of related experience; or,
• Equivalent combination of education and experience.
• May require certification in assigned area.
• Typically requires a minimum of seven-eight years of related experience and/or combination of experience and education/training.
• Experience in Biotech/Pharmaceutical industry preferred.
• Experience in Imaging Core Lab preferred.
• Experience in clinical operations is a plus.
• Experience in radiographic imaging in a clinical environment is a plus.
• Experience in RECIST 1.1 is a plus.
• Sound knowledge in Good Clinical Practice.
• Knowledgeable of the clinical trials process and/or experience working in an Imaging Core Lab environment preferred.
• Ability to communicate complex technical issues to non-technical stakeholders.
• Ability to prioritize and manage time sensitive tasks for multiple projects.
• Ability to work in a fast-paced environment.
• Strong organization and communication skills.
• Performs a variety of complicated tasks with a wide degree of creativity and latitude.
• Excellent attention to detail and orientation toward meticulous work.
• Proficient in Excel, Word, PowerPoint, and Visio
• Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
• Exercises independent judgment in methods, techniques, and evaluation of criteria for obtaining results.
• Creates formal networks involving coordination among groups.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.