Mgr, Clinical Operations Job

Employer Name: BiotechCrossing	SpiderID: 2324830
Location: San Diego, California	Date Posted: 6/30/2008
Wage:	Category: Biotech
Job Code:

Job Description:
The Power to Look Deeper? in developing the best products, technologies and service.Responsibilities Lead staff in designing and managing clinical trials within the Clinical Affairs Department. Represent Clinical Affairs in project Core Teams. Serve as liaison to other departments on matters related to clinical trials. Serve as point contact to outside clinical investigators and thought leaders in order to stay abreast of advances and keep them informed of developments within Gen-Probe Train staff in the Clinical Group(s) on how to conduct clinical trials in the blood screening and/or diagnostics areas. Work with the CDMS and Biostatistican to develop data models/analysis plans for clinical trials. Ensure regulations are consistent with FDA regulations for conducting clinical trials and documented accordingly. Negotiate clinical study budgets and research contracts with trial investigators and site personnel. Present and/or negotiate with FDA to gain approval of clinical study protocols, data analysis and clinical summaries. Manage clinical studies to ensure complete and accurate data collection. Prepare clinical reports summarizing the results of clinical trials consistent with clinical and regulatory requirements. Identify opportunities to develop scientific abstracts, presentations, and manuscripts for publication of clinical trial data. Take on departmental responsibilities including representing the department within Gen-Probe and at public meetings, including meetings with FDA. Provide guidance to junior staff personnel. Performs other related duties as assigned.

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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:

Contact Information:

Contact Name: -	Company Type: Employer
Company: BiotechCrossing

City: Pasadena
State: California
Zip:

Web Site: http://www.biotechcrossing.com