Clinical Trial Manager ensuring regulatory compliance and site performance for clinical studies at Syneos Health. Assessing site operations and supporting project team collaboration for successful outcomes.
Responsibilities
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.
Supports subject/patient recruitment, retention and awareness strategies.
Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
Requirements
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.
Benefits
Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition and total rewards program
Diversity of thoughts, backgrounds, cultures, and perspectives.
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