.**Local Trial Manager****-****2306137880W****Descripción**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.Position Summary:The Local Trial Manager II (LTM II) is responsible for local management of a clinical trial (or Medical Affairsdata generation activity) in a country or countries. The LTM II is the primary point of contact at a countrylevel for assigned studies and has operational oversight of assigned protocol(s) from start-up through todatabase lock and closeout activities as described in GCO procedural documents. The LTM II is responsiblefor coordinating and leading the local trial team to deliver quality data and trial documents/records that arecompliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), GoodClinical Practice (GCP), and regulatory requirements.The LTM II actively contributes to process improvement; training and mentoring of Clinical Trial Assistants(CTA), Site Managers (SM) and LTM I roles. The LTM II may have some site management responsibilities.The LTM II may also perform the role of Clinical Trial Manager (CTM)/Global Trial Lead (GTL) for singlecountry as described in GCO procedural documents.Principal Responsibilities:1. Collaborate with Functional Manager (FM)/Clinical Research Manager (CRM) for country protocolfeasibility (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), SM andCTM/GTL. Implements any local criteria for site selection. Ensure consistent conduct of pre-trialassessment visits and instruct teams on appropriate follow-up of pre-trial visit report and countryfeasibility report. Recommends suitable sites for selection to participate in trial.2. Collaborates with the Global Product Lead (GPL), CTM/GTL, local management/Country Head and otherstudy team member to select final site list.3
