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Sr. Clinical Study Manager · Stamford, CT
Demonstrated knowledge of, and competence in, application of FDA/GCP/ICH guidelines; good communication skills; knowledge and ability to effectively manage a clinical trial with minimal supervision.
Description
The Clinical Study Manager (CSM) organizes and facilitates the overall planning, coordination, tracking and general performance of clinical studies that support the Clinical Development Plan. The CSM is responsible for ensuring clinical study quality/consistency of performance and in conjunction with the Clinical Leader and all other Team members is responsible for overall timeline adherence and performance against plan of the clinical study. A critical component of the position is the peer management and/or support of and coordination with contract research organization personnel (CROs), consultants, contractors, and other colleagues to ensure adequate resource volume and quality is maintained on the studies for which the Clinical Study Manager is responsible. At times, business travel will be necessary. The incumbent requires superior written and verbal communication skills, peer management skills and must have a well-defined, effective system for multi-tasking. There...
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