Senior Site Manager

At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world. When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough. At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. We are Janssen. Our mission drives us. Our patients inspire us. Senior Site Manager - Buenos Aires, Argentina (remote) Purpose: The Senior Site Manager serves as the primary contact point between the Sponsor and the Investigational Site. The Sr. Site Manager is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study startup through to site closure. Responsibilities Act as primary local company contact for assigned sites for specific trials, may participate in site feasibility and/or pre-trial site assessment visits, and attend/participate in investigator meetings as needed. Execute activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management and site/study close-out according to SOPs, Work Instructions and policies. Implement analytical risk based monitoring model at the site level and work with the site to ensure timely resolution of issues found during monitoring visits. Ensure site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. In close collaboration with the LTM and central study team for the activities during site activation phase to speed up the process and activate the site in the shortest possible timeframe. Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas. Ensure site study supplies are adequate for trial conduct. Ensure site staff complete data entry and resolve queries within expected timelines. Ensure accuracy, validity and completeness of data collected at trial sites. Ensure that all Adverse Events (AE), Serious Adverse Events (SAEs) and Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate. Maintain complete, accurate and timely data and essential documents in relevant systems utilized for trial management. Fully document trial related activities, in particular monitoring. Write visit reports and follow-up letters in accordance with the SOPs. Promptly communicate relevant status information and issues to appropriate stakeholders. Review study files for completeness and ensure archiving retention requirements are met, including storage in a secure area at all times. Qualifications A minimum of a bachelor’s degree is required, preferably in a health or science related field. A minimum of four (4) years of experience is required. Experience in clinical trials or working as a Site Manager (CRA) is preferred. Good knowledge of ICH-GCP, Standard Operating Procedures (SOP), local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines is preferred. Strong IT skills in appropriate software and systems is preferred. This position may require up to 25% of travel. Proficiency in speaking and writing in English (intermediate level) is required. #J-18808-Ljbffr