|
Clinical Study Manager · Stamford, CT
Has demonstrated knowledge of, and competence in, application of CRFs, GCPs and ICH guidelines. Has demonstrated the use of good communication skills, command of medical terminology and of the application of scientific/medical and clinical concepts used to conduct Phase I-IV clinical trials.
Description
Responsible for planning, conducting and tracking clinical research studies in compliance with ICH/GCP/FDA guidelines and Purdue policies and Standard Operating Procedures, protocol specifications and Clinical Operations policies and Working Practice Documents. Is responsible for advising the Clinical Research Scientists on the clinical research site logistics and technical aspects of protocol conduct. The Clinical Study Manager will need to work directly with and the applicable Regional CRA Managers in order 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.
Experience and Skills:
A BS/BA in a health-care or science related field with a minimum of 5+ years of related experience in a pharma or CRO company.
Years of Experience
5
Additional...
|
|
