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Clinical Study Manager or Senior Clinical Study Manager Job
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| Employer Name: ClinicalresearchCrossing |
SpiderID: 2384507 |
| Location: Cambridge, Massachusetts |
Date Posted: 7/21/2008 |
| Wage: |
Category: Miscellaneous |
| Job Code: 6301039 |
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Job Description:
The CSM will also work secondarily in conjunction with the Director of Clinical Development responsible for the drug development program and all other functions responsible for supporting a clinical trial, e.g. Non-clinical personnel, data and safety analysis personnel. At times, business necessary travel will be required. 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.
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Job Requirements:
6301039
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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