Clinical Trials Manager

Restoration Robotics, Inc.

Location: Mountain View, California-Silicon Valley/Peninsula 94043
Posted on: 9/4/2008 1:22:46 PM
Postion type: Full time
Job Code: CTM-09-08
Required Education: Bachelor's Degree
Salary:

DESCRIPTION
Clinical Trials Manager for Medical Device Company

Leads, maintains, and supports clinical trial related activities.

Roles and Responsibilities:
* Initiation and monitoring of FDA IDE clinical sites.
* Serve as the primary company liaison for clinical sites. Manage site organization and resolve issues.
* Aid physicians and staff during clinical utilization of our product.
* Work closely with clinical investigators and clinical coordinators at clinical trial sites to train sites on clinical protocols and oversee adherence to clinical protocols.
* Conduct data collection at clinical sites.
* Develop and maintain clinical trials documentation and records.
* Conduct data analysis and write research reports.

REQUIREMENTS:
* Thorough working knowledge and experience with clinical research and methods and GCP (FDA 21 CFR).
* Must be able to develop competency and understanding of the company's medical device.
* 3-5 years experience clinical trials experience in the medical device industry.
* Must be proficient in reading the medical literature and technical writing.
* B.S. in life science; Master's Degree in epidemiology or public health preferred.
* Position will require travel (40%) during execution of clinical trials.
* Strong project management and computer skills (MS Excel, MS PowerPoint, MS Word).
* Candidate must be able to work independently with minimal supervision.

EOE. Label