Clinical Data Analyst

Há 2 dias

São Paulo, 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 waiting

What 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 www.nexcella.com

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