Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely)
Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions
Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient
Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site
Conducts Source Document Review of appropriate site source documents and medical records
Verifies compliance with electronic data capture requirements
Supports subject/patient recruitment, retention and awareness strategies

Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
Must demonstrate good computer skills and be able to embrace new technologies
Excellent communication, presentation and interpersonal skills
Ability to manage required travel of up to 75% on a regular basis

Clinical Trial Manager

Key skills