Senior Clinical Data Manager

hace 4 semanas

Madrid, España Empresa Reconocida A tiempo completo

.Johnson and Johnson is currently seeking a Senior Clinical Data Manager located in Titusville, NJ; Raritan, NJ; OR Spring House, PA. Remote work options in the United States may be considered on a case-by-case basis and if approved by the company. 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.The Senior Clinical Data Manager provides oversight and accountability and/or executes data management activities and/or performs scientific data review for multiple low, moderate, and high complexity trials.The Senior Clinical Data Manager makes recommendations and decisions that have an impact on processes, timing, and structure for trials and assignments with minimal direction from manager or Data Management Leader (DML). This position also makes recommendations for processes, timing, structure, and resources at a program level. Work is received in broad terms, reviewed during major deliverables, and the amount of instruction is limited. Work is reviewed with the Data Management Leaders or the immediate manager as needed.Primary Responsibilities: Take a leadership role with external suppliers, trial customers, and other internal/external partners to establish, align and confirm data management and/or clinical data management expectations to the business for assigned trial(s).Gather and/or review content and integration requirements for eCRF and other data collection tools.Establish conventions and quality expectations for clinical data.Establish expectations for dataset content and structure.Set timelines and follow-up regularly to monitor delivery of all data management milestones.Ensure accurate review of related clinical data management documents as well as compliance with regulatory guidelines and documentation requirements.Ensure real-time inspection readiness of all DM deliverables for the trial; participate in Regulatory Agency and J&J internal audits as necessary.Lead the planning and tracking of content, format, quality, and timing of applicable data management deliverables. Ensure deliverables are on time.Take a leadership role to obtain and share best practices with internal partners.Identify and communicate lessons learned, best practices and frequently asked questions at the trial level.Create key functional plans (e.G. study Integrated Review Plan) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.Identify and participate in process, system, and tool improvement initiatives

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