Clinical Data Specialist Zeltiq Aesthetics, Inc.
THIS JOB HAS EXPIRED Description
ZELTIQ's first commercial product, the CoolSculpting System, is designed to selectively reduce stubborn fat that may not respond to diet or exercise. CoolSculpting is based on the scientific principle that fat cells are more sensitive to cold than the overlying skin and surrounding tissues. It utilizes patented technology of precisely controlled cooling to reduce the temperature of fat cells in the treated area, which is intended to cause fat cell elimination through a natural biological process known as apoptosis. Zeltiq developed CoolSculpting to safely, noticeably and measurably reduce the fat layer. Zeltiq is an equal opportunity employer.
Works with Clinical Affairs team to ensure the organization and accuracy of all study related databases, to include but not limited to: case report forms, laboratory and ultrasound images as well as photographs and other clinical images.
Works with the Clinical team to create case report forms and other clinical documents as required to support clinical studies. Writes reports of the results of clinical testing and performs literature reviews and summaries as appropriate.
Works with research scientist to prepare/test lab samples, photograph slides and perform basic computer analysis.
Essential Duties and Responsibilities include the following (other duties may be assigned.):
? Interact with the project team on study startup, database set-up, data entry and study close-out, in accordance with specific study protocol to ensure timely data transfer.
? Verify the information in the databases for outcomes management, and report data errors or missing information to appropriate individuals.
Maintain literature review database.
? Slide photography, organization and management.
? Assist with organization of laboratory and maintenance of lab devices.
? Data entry and basic computer analyses
? Sample testing (with a validated protocol)
Other Duties and Responsibilities:
? Assist in study report/summary preparation. Summarize and write reports of clinical study results as appropriate.
? Basic statistical data analysis under the direction of Sr. Research Scientist and/or consulting statistician
Perform other related duties as assigned.
? Bachelor?s Degree in life science with basic understanding of research concepts
? Excellent organizational and written communications skills; attention to detail.
? Ability to produce accurate work to tight deadlines
? Competence in performing general functions within MS-Office software, specifically, Microsoft Word and Excel and Powerpoint.
? Laboratory duties require completion of blood borne pathogen training. Training will be provided after the employee is hired.
? Responsible for performing all duties in compliance with FDA?s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ZELTIQ complies.
||Pleasanton, CA |
THIS JOB HAS EXPIRED