Clinical Research

• Manage day-to-day clinical trial management activities, supporting your team to deliver quality outcomes
• Plan and manage all aspects of clinical trials, ensuring adherence to timelines, budget, and quality standards
• Collaborate with cross-functional teams to establish and implement clinical trial protocols and procedures
• Build and manage strong relationships with trial investigators and stakeholders
• Ensure all trials are conducted in compliance with local, national, and international regulations and ethical guidelines
• Problem-solve and make critical decisions regarding trial design, vendor selection, and risk management

Clinical Trial Manager

• 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 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
• Demonstrates diligence in protecting the confidentiality of 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
• Assesses site processes
• Conducts Source Document Review of appropriate site source documents and medical records
• Applies query resolution techniques remotely and on site
• Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture

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Clinical Trial Manager

Clinical Trial Manager – CTM, Argentina, Brazil, Chile, Colombia, Mexico