Clinical Document Management Specialist
1 week ago
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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