Senior Manager Clinical Affairs - NEEDED NOW!

Apply by eMail:15331211.185@jobfrenzy1.com

Description:
Job Description: WHY WAIT? Are you looking for an exciting new opportunity? This may be your lucky day! It is time for a change, and CDI can help! We have an immediate need for a Senior Manager Clinical Affairs JOB DESCRIPTION Our client, a fortune 100 international manufacturing giant, seeks a Senior Manager Clinical Affairs candidate for their medical diagnostic devices division in Los Angeles California. If interested, please forward resume with salary requirements. Responsible for project leadership of selected clinical studies devising and executing strategies for the clinical and nonclinical (analytical) trials for product releases, regulatory filings, product modifications/claim extensions, and/or new markers. Supports the Head of Clinical Affairs and the company in the design and preparation of clinical study protocols and the design, initiation, monitoring, and close-out of clinical studies for validation of all X Healthcare Diagnostics in vitro diagnostic products. Provides expert resources to project teams on the requirements and conduct of successful clinical trials in multiple disease-focus or other areas. Ensures adherence to Good Clinical Practice (GCP) and department standard operating procedures for conducting in vitro diagnostic device clinical studies. Prioritizes and focuses resources to deliver all projects in a timely manner in keeping with the groups commitments. SUPERVISORY RESPONSIBILITIES Directly supervises two or more employees in the Department of Clinical Affairs. Carries out supervisory responsibilities in accordance with the organizations policies and applicable laws including interviewing, hiring and training employees; planning, assigning, and directing work; appraising performance; maintaining staff training files, rewarding and disciplining employees; addressing complaints and resolving problems. ESSENTIAL DUTIES AND RESPONSIBILITIES Other duties may be assigned. - Coordinates all activities related to the design and management of clinical trials of in vitro diagnostic devices. - Researches scientific evidence, appropriate CLSI documents, and current clinical use of in vitro assays in preparation for clinical protocol development. - Designs and prepares clinical trial plans and protocols, as well as case report forms, investigator or site-specific instruction manuals and other related study documentation. - Monitors proposed regulations and guidance documents that concern clinical trials ensuring that Clinical Affairs group remains compliant with all current and new regulations and requirements for clinical trials and protection of human subjects. - Assists in responses during regulatory body review of product submissions. TAKE ACTION! Why wait another day? It is time to act! Apply NOW and join the CDI Team TODAY! Experience:

Requirements:
See Above

Education: Not Specified

Experience: Not Specified

Travel: Not Specified

Apply by eMail:15331211.185@jobfrenzy1.com

Job Created: Fri Oct 16 2009 04:27:20 AM
Last Modified: Fri Oct 16 2009 04:27:20 AM