Clinical Data Analyst

Há 4 dias

Belo Horizonte, 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 CTU's 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; • Contribute to services offered by the CTU to the wider LSHTM community in line with the post-holder's expertise.• Undertake any other reasonable duties as required by the Senior Data Manager or other senior CTU staff commensurate with the level of this post.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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