Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits
Uses judgment and experience to evaluate overall performance of site and site staff
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
Assesses factors that might affect subject/patient’s safety and clinical data integrity

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
committed to building an inclusive culture

Clinical Trial Manager I – Sponsor Dedicated

Key skills