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Senior Clinical Research Manager Job
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| Employer Name: ClinicalresearchCrossing |
SpiderID: 2385552 |
| Location: Santa Rosa, California |
Date Posted: 7/22/2008 |
| Wage: |
Category: Miscellaneous |
| Job Code: 6559300 |
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Job Description:
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 and provide oversight of data correction. Work with Clinical Customer Service to control device allocation, distribution, and reconciliation. Manages activities performed by Contract Research Organizations (e.g. CROs, core labs).. Oversees the clinical department SOP/DOP review and development, employee training, and associated requirements. Evaluate clinical data/information, write, and revise annual, interim, and final reports and clinical sections of Pre-Market Approval (PMA) submissions. May organize and direct investigator conferences to review findings and advise on study direction, as needed. Provide input and support for post-clinical activities and market launch of products. May co-author results of studies for medical literature and/or presentations at scientific meetings.
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For further information, please visit us online at http://www.clinicalresearchcrossing.com
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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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