Clinical Study Manager or Senior Clinical Study Manager Job

Employer Name: ClinicalresearchCrossing	SpiderID: 2385599
Location: Cambridge, Massachusetts	Date Posted: 7/22/2008
Wage:	Category: Miscellaneous
Job Code: 6301039

Job Description:
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. 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.

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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

City: Pasadena
State: California
Zip:

Web Site: http://www.clinicalresearchcrossing.com