Trial Master File

2 semanas atrás

São Paulo, Brasil Nexcella, Inc. Tempo inteiro

Trial Master File (TMF) Specialist Greater Sao Paulo Area / Hybrid Greater Rio de Janeiro Area / Hybrid Our 3 Core Values • Intelligence • Integrity • Initiative Our mission is to harness the immune system through innovative cell therapies and other modalities to deliver widely accessible cures. Patients are waiting What You'll Do As a TMF Specialist you will complete Document Management activities in support of client services contracts and clinical trial needs. Process study documents in accordance with client and study requirements as per study-specific processes, SOPs/WPs and regulations, where applicable. Liaise with study teams and other TMF staff in order to fulfill job responsibilities and activities. Complete departmental projects as assigned in accordance with specified timelines, SOPs/WPs and regulations. Maintain study files as per study and/or client requirements or in accordance with SOPs/WPs and applicable regulations. Complete activities related to document receipt and processing which may include but is not limited to: document receipt and review, scanning and indexing, quality control, copying, filing, forwarding or return to client/study teams and archiving. Provide information necessary to complete client and/or departmental status reports as requested by the management of TMF department. Inform the Manager of training issues, project activities, quality issues and timelines as directed. Participate in audits and document archiving activities as necessary. Participate in training related to fulfillment of responsibilities as required by company and/or the client. What We Look For 2+ years of TMF (Trial Master File) experience and strong knowledge of Clinical Studies documents. TMF (Trial Master File) experience and strong knowledge of Clinical Studies documents. Ability to successfully liaise with study project teams, staff, and management, as necessary. Bachelor's Degree in Life Science preferred About Nexcella Nexcella Inc., a wholly-owned Immix Biopharma subsidiary, is a clinical-stage biopharmaceutical company trailblazing cell therapies in AL Amyloidosis and other serious diseases. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201. Learn more at

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