Report Reviewer

• Execute Central Report Review activities on studies according to the monitoring strategy, focusing on patient safety, protocol/GCP/regulatory compliance and data integrity
• Support development of annotated visit reports such as PSV, SIV, IMV, COV and SCAN
• Review the content and quality of site and central monitoring documentation, including site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence
• Document requested revisions and approvals in CTMS and ensure deliverables meet company and/or sponsor specifications and deadlines
• Assess factors affecting subject/patient safety and clinical data integrity, including protocol deviations, violations, sponsor requirements and pharmacovigilance issues
• Immediately communicate or escalate serious issues to the Clinical Trial Manager or Project Manager
• Document review observations and report protocol deviations or action items in appropriate systems
• Assess CRA/CM report quality, risks, trends and operational performance, and summarize findings for CTM review and action planning
• Participate in clinical monitoring/project staff meetings and clinical training sessions
• Maintain current project status knowledge through project discussions and email correspondence
• Support CTM activities such as Protocol Deviation management and Action Items management

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• Capable of working in an international environment
• Previous clinical trial experience in site management and clinical preferred
• Preferred experience in study management, such as Lead CRA or equivalent
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Good documentation habits and skills
• Strong attention to detail
• Good computer skills and ability to learn new technologies
• Good communication and interpersonal skills among project team and with sites
• Critical thinking and problem-solving skills
• Understanding of protocol, SOPs, ICH GCP and country regulations

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition
• Total rewards program
• Inclusive culture
• Reasonable accommodations for applicants with disabilities, when appropriate