Lead Site Manager (Lead CRA - Monitor de Pesquisa Clínica Lead)

Johnson & JohnsonSão Paulo, BrazilonsiteSalary not postedView the original posting at Johnson & Johnson ↗

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: R&D Operations Job Sub Function: Clinical Trial Support Job Category: Professional All Job Posting Locations: São Paulo, Brazil Job Description: Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at: https://www.jnj.com/innovative-medicine We are searching for the best talents for tthe Lead Site Manager (home based). This is a home-based role, with a preference for candidates located in São Paulo. Purpose: A Lead, Site Manager is considered as the most senior site management role with typically more than 6 years of experience. This role serves as the primary contact point between the Sponsor and the Investigational Site. Additionally, a Lead, Site Manager is generally expected to have outstanding capability to engage with key sites and their respective personnel. A Lead, 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 start-up through to site closure. Responsibilities may include assisting with site selection, site qualification assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities. The Lead, Site Manager will partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and TDL (Trial Delivery Leader) to ensure overall site management while performing trial related activities for assigned protocols. A Lead, Site Manager is expected to lead process improvements at country, regional, and global levels as well as training and mentoring of other Site Managers. A Lead, Site Manager is expected to operate independently and be able to perform clinical trial tasks proficiently and is expected to identify opportunities for streamlining processes. Additionally, a Lead, Site Manager is expected to oversee, train and mentor more junior Site Managers when required. Lead, Site Manager can support leadership at a study level as requested. Principal Responsibilities: Acts as primary local company contact for assigned sites for specific trials. Actively participate and provide in-depth insights in site feasibility and/or Site Qualification Visit. Leads investigator meetings as needed. Presents study updates and facilitates discussions between meeting participants. 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 dur

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