Clinical Trial Manager Job

Employer Name: BiotechCrossing	SpiderID: 2206741
Location: Fremont, California	Date Posted: 4/28/2008
Wage:	Category: Biotech
Job Code:

Job Description:

Perform independent monitoring of sites including: conducting site pre-qualification, initiation, monitoring visits, and close-out visits. Maintain frequent contact with and work effectively with investigators and coordinators - Design study documents including, but not limited to clinical protocols, case report forms, site study procedure manuals and project tools, monitoring plans, tracking tools, and informed consent forms. - Prepare and track timelines and required documentation from clinical sites and /or a full service CRO - Review and resolve discrepancies in clinical data with clinical sites or through a full service CRO. - Provide guidance, clinical trial management expertise, and direction to in-house and contract CRAs in the field. - Assist the senior management in review of clinical study reports, budget and contract negotiation. Assure regulatory compliance of investigational sites with company SOPs, FDA and ICH guidelines. - May be required to travel up to 30% Requirements - 3+ years monitoring; and 2+ years as a CRA at a sponsor company and CRO management experience. - Demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations and experience with all phases of a study (qualification through final study report generation). - BS in a scientific discipline, or health-related field, five or more years of relevant experience including leadership experience within clinical research. -CNS, CV and/or GI experience - Demonstrated problem solving abilities in overseeing clinical studies, and demonstrate tactfulness and diplomacy in dealing with study coordinators and physicians.

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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