Who is Janssen? We’re more than 30,000 people working hard to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. From heart disease to HIV, Alzheimer’s disease to cancer, we are committed to issues that touch everyone’s lives. Our mission is to transform individual lives and fundamentally change the way diseases are managed, interpreted, and prevented. We believe that challenging something is the best way to change it. So every day, in more than 150 countries, we bring ground breaking science and the most creative minds in the industry together to think differently about diseases. We seek not only to innovate but also to empower people with the tools they need to make informed decisions and achieve the best possible results for their health. Main Responsibilities: - Acting as primary local company contact for assigned sites for specific trials. - Site feasibility and/or pre-trial site assessment visits - Attending/participating in investigator meetings as needed. - Responsible for executing activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. - Responsible for the implementation of analytical risk based monitoring model at the site level and to work with site to ensure timely resolution of issues found during monitoring visits. - Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with LTM and central study team for the activities during site activation phase in order to speed up the process and activate the site in the shortest possible timeframe. - Participating in site level recruitment strategy and contingency planning and implementation in partnership with other functional areas. - Ensuring site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct. - Ensuring that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented. - Arranges for the appropriate destruction of clinical supplies. - Ensuring site staff complete data entry and resolve queries within expected timelines. - Ensuring accurate, valid and complete data collection at trial sites - Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs )/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents. - Maintains complete, accurate and timely data and essential documents in relevant systems utilized for trial management. - Fully documents trial activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate partners. - Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times. - Collaborates with LTM for documenting and communicating site/study progress / issues to trial central team. - Attends regularly scheduled team meetings and trainings. - Works closely with LTM to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified on site during routine monitoring and other visit types, e.g. On Site Quality Monitoring Visit (OSQMV). - Prepares trial sites for close out, conduct final close out visit! - Tracking site costs and ensure payments are made, if applicable. - May participate to process improvement and training! Qualifications - BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) - Strong proven understanding of GCP, company SOPs, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines. - Strong IT skills in appropriate software and company systems. - Willingness to travel with occasional overnight stay away from home. - Good English and Italian level. For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we in Italy are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are v