Clinical Data Analyst

Há 8 horas


Sergipe, Brasil Nexcella, Inc. Tempo inteiro

Clinical Data Analyst (Cell Therapy)Greater São Paulo 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 waitingWhat You'll Do Conduct data entry, data review checks and query management of trial data; Assist with review of data quality and with completing actions that arise from Data Quality Control checks; Provide guidance to site investigators on how to complete relevant forms and use the Data Management Systems; Check and identifying problems with data received from trial sites, escalating any data concerns as appropriate, including Adverse Event (AE) coding; Liaise with site investigators and trial teams to resolve data queries and problematic data under the supervision of the Data Manager and in line with written procedures; Conduct checks of all data received by site investigators in line with written procedures, to ensure compliance with the trial protocol and data collection guidance; Handle and storing data and relevant documentation in line with written procedures, ICH GCP and General Data Protection Regulation (GDPR); Test and document the trial and Data Management systems, in line with written procedures; To assist Data Ensure all data and documentation are readily accessible for independent audits and inspections; Handle and store all data and corresponding communications per written procedures and in line with relevant regulations, Good Clinical Practice (GCP) and General Data Protection Regulation (GDPR); File important trial documents in the Trial Master File (TMF) and assist with archiving as per written procedures; What We Look For: Bachelor's degree At least 1 year of working experience in Clinical data at a CRO or sponsor, 2+ years preferred Proficient knowledge and practical utilization of ICH- GCP and applicable regulatory requirements. 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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