Clinical Research Associate (CRA) / Senior Site Manager

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. The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g., multiple myeloma and prostate cancer), immunology (e.g., rheumatoid arthritis, irritable bowel disease and psoriasis), neuroscience (e.g., schizophrenia, dementia and pain), infectious disease (e.g., HIV/AIDS, Hepatitis C and tuberculosis), cardiovascular and metabolic diseases (e.g., diabetes) and Pulmonary Arterial Hypertension (PAH) and Rare Diseases. A Site Manager serves as the primary contact point between the Sponsor and the Investigational Site. This role 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 start-up through to site closure. Responsibilities may include assisting with site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities. The Site Manager will partner with the Local Trial Manager, Clinical Trial Assistant and Clinical Trial Manager to ensure overall site management while performing trial related activities for assigned protocols. Main Responsibilities: -Acts as primary local company contact for assigned sites for specific trials. -Responsible for executing 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. -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. -Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented. -Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs)/Product Quality Complaints 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 related 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 stakeholders. -Attends regularly scheduled team meetings and trainings. -Prepares trial sites for close out, conduct final close out visit. -Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff. Qualifications Education level: A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required. Experience required: A minimum of 6 years of clinical trial monitoring experience Willingness to travel with occasional overnight stay away from home (25% of time approx). Language: Proficient in speaking and writing the country language. English at least intermediate level. Ability to mentor/coach junior flex people Ability to lead initiatives May act as Lead SM-training other SMs on study May take over LTM role reports review (SQV, SMV, SCV) for sites assigned to other SMs from the same trial May develop site start up documents for studies including SIV agenda, ICFs, etc May provide SM “voice” when reviewing study documents (e.g. Monitoring Guidelines) May represent SMs on SMTs/meetings Able to work on multiple trials in different disease areas May have specialized experience Strong leadership skills are required May support country budget development and/or contract negotiation in liaison with CCS colleagues Location: Buenos Aires, Argentina Primary Location Argentina-Buenos Aires-- Organization Janssen Cilag Farmaceutica Srl (fka Pharma Farmace (7425) Job Function R&D Requisition ID 2206014522W