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Clinical Study Manager or Senior Clinical Study Manager Job
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| Employer Name: PharmaceuticalCrossing |
SpiderID: 2359085 |
| Location: Cambridge, Massachusetts |
Date Posted: 7/10/2008 |
| Wage: |
Category: Medical/Health |
| 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 a 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. • Assist with preparing and presenting information at investigator's meetings. • Create template presentations for SEVs and SIVs visits. Ensure adequate team review of materials. • Prepare and/or ensure preparation of study-specific training materials for Clinical Research Associates. • Co-monitor with Regional CRAs to evaluate protocol-specific monitoring practices. • Maintain periodic contact with and update training for Regional Clinical Research Associates regarding monitoring and site management activities related to a clinical protocol. • Review site visit reports from CRAs, evaluating and reporting trends to the Clinical Development Team and serious gaps in GCP compliance to Quality Assurance. • Manage the central lab communications regarding site performance and needs.
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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: PharmaceuticalCrossing |
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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.pharmaceuticalcrossing.com
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