Clinical Document Management Specialist

1 week ago


El Segundo, California, United States ImmunityBio Full time
Clinical Document Management Specialist

At ImmunityBio, we are seeking a highly organized and detail-oriented Clinical Document Management Specialist to support our clinical trials team. As a Clinical Document Management Specialist, you will be responsible for processing and managing clinical trial documents, ensuring compliance with regulatory guidelines and company SOPs.

Key Responsibilities:

  • Process and manage clinical trial documents, including filing, routing, and coordination
  • Assist with the setup, organization, maintenance, and close-out of study-specific TMF/eTMF
  • Maintain and update the Company's standard TMF Plan and TMF index
  • Collaborate with clinical study teams to guide proper submission and/or filing of clinical study-related documents
  • Perform and oversee a review of documents filed in the TMF/eTMF

Requirements:

  • Bachelor's degree with 1+ years of clinical operations experience in pharma, biotech, or CRO
  • High School diploma with 4+ years of clinical operations experience in pharma, biotech, or CRO
  • Demonstrated knowledge of clinical trial documents
  • Proficiency in MS Word, Excel, PowerPoint, and Outlook

What We Offer:

  • Competitive hourly rate of $50-$36
  • Medical, dental, and vision plan options
  • Health and financial wellness programs
  • Employer assistance program (EAP)
  • Company-paid and voluntary life/AD&D, short-term and long-term disability
  • Healthcare and dependent care flexible spending accounts
  • 401(k) retirement plan with company match
  • 529 education savings program
  • Voluntary legal services, identity theft protection, pet insurance, and employee discounts, rewards, and perks
  • Paid time off (PTO) includes 11 holidays, exempt employees eligible for unlimited PTO, and non-exempt employees eligible for 10 vacation days, 56 hours of health pay, 2 personal days, and 1 cultural day


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