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Senior Clinical Research Manager Job
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| Employer Name: ClinicalresearchCrossing |
SpiderID: 2379761 |
| Location: Santa Rosa, California |
Date Posted: 7/19/2008 |
| Wage: |
Category: Miscellaneous |
| Job Code: |
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Job Description:
Research, prepare, and revise the Investigational Plan (study protocol, Instructions For Use (IFU), report of prior Investigations, bibliography, Case Report Forms (CRFs), etc.) and other appropriate sections of the Investigational Device Exemption (IDE) in consultation with the cross-functional project team, investigators, data management, and biostatistics. Provides management review and approval of relevant clinical documents. Supervise training of investigators, site staff, and Medtronic clinical staff. Supervise site initiation activities. Oversee set-up and maintenance of accurate study status and implant logs. Interfaces with representatives from key functional groups (Research & Development, Manufacturing, Sales, Marketing, Regulatory Affairs, and European Clinical Groups) to drive clinical wide or cross-departmental initiatives. Develop and manage cost center budget and study budgets. Ensures appropriate resources and priorities are maintained for the various projects assigned to their area. Oversees Clinical Research staff with all aspects of their responsibilities. May interface with regulatory agencies, as appropriate. Collaborate with Clinical Operations department to coordinate field staff and clinical site activities with study needs. Compile, review, and conclude device complaints. Provide management level representation during audits. Performs personnel related supervisory duties (e.g., performance assessments, development of staff goals and objectives)..
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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: ClinicalresearchCrossing |
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| City: Pasadena |
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| State: California |
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| Zip: |
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Web Site: http://www.clinicalresearchcrossing.com
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