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Clinical Study Manager or Senior Clinical Study Manager Job
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| Employer Name: ClinicalresearchCrossing |
SpiderID: 2379790 |
| Location: Cambridge, Massachusetts |
Date Posted: 7/19/2008 |
| Wage: |
Category: Miscellaneous |
| Job Code: |
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Job Description:
Over a twelve-month period, the travel is estimated to be not more than 25% of this function. For brief periods, e.g. one calendar month, the travel percentage could be as high as 40%. Should the travel rate for the clinical CMS become significantly higher than 25% at baseline, special work time considerations will be agreed upon between the CSM and his or her direct supervisor in coordination with the Director of Clinical Development. Specialty CSM Functions: (depending on the position being recruited) The Clinical Study Manager - Clinical Pharmacology also will have responsibility for advising the Clinical Development Team and Pharmacologist on the clinical research site logistics and technical aspects of protocol conduct. The Clinical Study Manager - Pediatrics also will have responsibility for advising the Clinical Development Team on the clinical research site logistics and technical aspects of protocol conduct. Responsibilities for this position: A successful CSM will conduct the following in accordance with SOPs, FDA/GCP and ICH guidelines with minimal supervision: Review protocols and give advice to the Clinical Development Team regarding logistics involved in the conduct of the protocol. Informed consent template development and review. Develop Monitoring Plan and protocol - specific CRF completion instructions. Prepare or ensure preparation of CRF training materials for CRAs and site personnel. Potential site recruitment vendor evaluation. Create subject recruitment plan that will meet planned study enrollment rates. Ensure adequate and accurate site recruitment activities are performed. With the CPM and Contracts Manager, set-up protocol-specific work orders with central vendors, e.g. laboratories, ECG over read facilities, etc.
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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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Web Site: http://www.clinicalresearchcrossing.com
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