Clinical Operations

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (on-site or remotely)
• Evaluates overall performance of site and site staff and provides recommendations and action plans
• Maintains working knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes
• Verifies informed consent processes and protects subject/patient confidentiality
• Assesses factors affecting subject safety and clinical data integrity, including protocol deviations and pharmacovigilance issues
• Conducts source document review and verifies clinical data entered in CRFs
• Applies query resolution techniques and drives query closure within timelines
• Utilizes hardware and software to support clinical data review and capture; verifies EDC compliance
• Performs IP inventory, reconciliation, and verifies IP handling per protocol
• Reviews and reconciles Investigator Site File (ISF) with Trial Master File (TMF) and ensures archiving of essential documents
• Documents activities via confirmation/follow-up letters, trip reports, communication logs, and tracking systems
• Supports subject recruitment, retention and awareness strategies
• Manages site-level activities, communications, budgets and timelines to meet project objectives
• Acts as primary liaison with project site personnel or collaborates with CRA/CMA; ensures training and compliance
• Prepares for and attends Investigator Meetings and sponsor meetings; participates in global monitoring/project meetings
• Provides audit readiness support and prepares for audits; supports required follow-up actions
• For Real World Late Phase: provides site support throughout study lifecycle and conducts chart abstraction and data collection

Clinical Operations · Sweden Jobs