Johnson & Johnson - Montpelier, VT
posted 2 months ago
Johnson and Johnson Innovative Medicine is seeking a Local Trial Manager (LTM) for Cross Therapeutic Areas, responsible for the local management of clinical trials or Medical Affairs data generation activities across the United States. The LTM serves as the primary point of contact for assigned studies at the country level, overseeing operational aspects from trial start-up to database lock and closeout activities, in accordance with GCO procedural documents. This role requires coordination and leadership of the local trial team to ensure the delivery of quality data and compliance with clinical trial protocols, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements. The LTM actively contributes to process improvement initiatives and is involved in the training and mentoring of Clinical Trial Assistants (CTAs) and Site Managers (SMs). In some cases, the LTM may also take on site management responsibilities and may perform the role of Clinical Trial Manager (CTM) or Global Trial Lead (GTL) for single-country trials. The position emphasizes collaboration with various stakeholders, including Functional Managers, Clinical Research Managers, and Global Product Leads, to ensure effective site selection and trial execution. Key responsibilities include conducting feasibility assessments, leading local project planning activities, ensuring timely reporting of Adverse Events (AEs) and Serious Adverse Events (SAEs), maintaining trial management systems, and managing local study budgets. The LTM is also responsible for preparing informed consent documents, ensuring compliance with local regulatory requirements, and fostering strong relationships with external stakeholders such as investigators and site staff. This role is critical in ensuring that clinical trials are conducted efficiently and in compliance with all applicable regulations and standards.