Clinical Trial Manager I – Sponsor Dedicated

• Perform site qualification, site initiation, interim monitoring, site management, and close-out visits on-site or remotely
• Evaluate site and site staff performance and provide site-specific recommendations
• Escalate serious issues and develop action plans with project team guidance
• Verify informed consent processes, subject/patient confidentiality, safety, and clinical data integrity
• Assess site processes under Clinical Monitoring/Site Management Plans
• Conduct source document review and verify clinical data in case report forms
• Resolve queries remotely and on site within agreed timelines
• Use hardware and software for clinical project data review and capture
• Verify electronic data capture compliance
• Manage investigational product inventory, reconciliation, storage, dispensing, administration, and related documentation
• Review Investigator Site Files and reconcile them with Trial Master Files
• Document monitoring activities through letters, trip reports, communication logs, and project documents
• Support subject/patient recruitment, retention, and awareness strategies
• Track observations, site status, and action items to resolution
• Manage site-level activities and communications to meet project objectives, deliverables, and timelines
• Liaise with project site personnel, CRAs, and Central Monitoring Associates
• Ensure assigned sites and site team members are trained and compliant
• Attend investigator, sponsor, global monitoring, and clinical training meetings
• Support audit readiness, audit preparation, and follow-up actions
• For Real World Late Phase: provide site support throughout the study lifecycle, perform chart abstraction and data collection, and collaborate with sponsor affiliates, medical science liaisons, and local country staff

• 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
• Good computer skills and ability to embrace new technologies
• Excellent communication, presentation and interpersonal skills
• Ability to manage required travel of up to 75% on a regular basis
• Ability to perform clinical monitoring and site management activities on-site or remotely
• Knowledge of local requirements for real world late phase study designs, where applicable

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition
• Total rewards program
• Total Self culture
• Diversity, inclusion, and belonging initiatives