Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance
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 such as protocol deviation/violations and pharmacovigilance issues

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

We are passionate about developing our people, through career development and progression
supportive and engaged line management
technical and therapeutic area training
peer recognition and total rewards program
inclusive culture – where you can authentically be yourself

Clinical Country & Site Associate – Clinical Trial Manager

Key skills