Perform site visits and monitor activities in accordance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements. Assess and ensure overall integrity of study and adherence to guidelines, protocols, and regulations. Evaluate overall performance of site and site staff. Ensure compliance and understanding of study requirements by site contacts. Apply judgment and knowledge to independently resolve site issues. Interpret data to identify protocol deviations or major risks to data integrity. Provide recommendations regarding site-specific actions and use judgment and experience to assess ability of site staff Understand project scope, budgets, and timelines and be able to provide input and manage project objectives to meet timelines. Act as a liaison between the company and study site personnel and be able to respond to site concerns and questions. Review and verify case report forms and other clinical data for completeness and accuracy. Monitor patient safety, identify and address any protocol deviations. Generate queries and manage resolutions with site personnel. Participate in the identification and selection of investigators and clinical sites. Maintain project tracking systems as required. Work with junior staff on training, guidelines, and processes. Complete assigned training programs and apply learning. Maintain working knowledge of GCP/ICH Guidelines as well as all applicable regulations.
Bachelor's degree or RN in a related field or equivalent combination of education, training and experience Two to three years prior clinical monitoring experience Knowledge of Good Clinical Practice (GCP)/ICH Guidelines and other applicable regulatory requirements Strong organizational skills Must demonstrate good computer skills. Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade Heavy travel required (up to 70% in peak time)
For further details or to apply please reach out to Magdalena Raczynska, Recruiter EMEA on