Clinical Document Management Specialist

📋 Description

• • The Clinical Document Management Specialist supports clinical trials by processing paper and electronic essential study documents against quality criteria, ensuring compliance with SOPs and regulatory guidelines.
• • Day-to-day responsibilities include setting up, organizing, maintaining, and closing out study-specific TMF/eTMF; maintaining the company’s TMF Plan and index; overseeing document reviews; collaborating with clinical study teams; performing QC checks; supporting audits; and handling ad-hoc projects.
• • The role is part of ImmunityBio, a commercial-stage biotechnology company developing cell and immunotherapy products to strengthen the immune system against cancer and infectious diseases, headquartered in Southern California with remote work options.
• • The specialist will gain expertise in clinical trial document management, regulatory compliance (ICH/GCP), TMF/eTMF systems, cross-functional collaboration, and audit readiness, with opportunities for professional development in a growing, publicly traded biopharmaceutical organization.