Clinical Country & Site Associate – Clinical Trial Manager
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Job Description
Clinical Country & Site Associate role ensuring compliance in clinical trials. Collaborate with teams to manage site activities and ensure regulatory adherence.
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
- 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
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:
- 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
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