Clinical Document Management Specialist
ImmunityBio, Inc.
4 hours ago
Remote friendly (California, United States)
United States
Operations
Position Summary
The Clinical Document Management Specialist supports clinical trials by processing paper and electronic essential study documents against pre-specified quality criteria, including filing, routing, and coordination of documents to ensure compliance with applicable SOPs and regulatory guidelines.
Essential Functions
- Assist with setup, organization, maintenance, and close-out of study TMF/eTMF.
- Maintain and update the Company’s TMF Plan and TMF index (indexing, tracking, and filing paper and electronic clinical trial documents).
- Maintain the study TMF filing records system.
- Collaborate with Clinical Study teams to guide proper submission and/or filing of clinical study documents.
- Perform and oversee review of documents filed in the TMF/eTMF per SOPs, processes, procedures, and work instructions.
- Prepare, handle, distribute, file, and archive clinical documentation and reports per standard procedures.
- Collaborate on review and improvement of SOPs and departmental policies related to TMF maintenance and archiving.
- Perform regularly scheduled QC of TMF/eTMF per the TMF Plan by monitoring completeness and quality.
- Support internal audits and Regulatory Agency inspections by retrieving documents and providing reports.
- Perform ad-hoc/cross-functional duties and/or projects as assigned.
Education & Experience
- Bachelor’s degree with 1+ years of clinical operations experience in pharma/biotech/CRO required; or
- High School diploma with 4+ years of clinical operations experience in pharma/biotech/CRO required.
- Trial Master File experience preferred.
Knowledge, Skills, & Abilities
- Knowledge of ICH and GCP guidelines.
- Knowledge of clinical trial documents preferred.
- Proficiency in MS Word, Excel, PowerPoint, Outlook.
- Independent and flexible; able to self-direct, adapt to changing priorities, and meet tight deadlines.
- Understand and follow job-specific systems/processes defined by Company SOPs; notify supervisor/manager if unclear.
- Strong communication skills and customer focus; ability to interact cross-functionally.
- Maintain corporate confidentiality; dependability and timeliness.
- Critical thinking, strong attention to detail, document organization, prioritization, scheduling, and meeting deadlines.
Working Environment
- On-site in El Segundo, CA or Remote.
- Monday–Friday within standard business hours (flexibility with manager approval).
- On-call during audits.
Benefits
- Discretionary bonus and equity award.
- Medical, Dental and Vision plan options; health and financial wellness programs; EAP; life/AD&D; short-term and long-term disability; healthcare and dependent care FSAs; 401(k) match; 529 education savings; PTO (11 holidays; unlimited PTO for exempt employees; non-exempt vacation/health pay/personal/cultural days).
Application Instructions
- The application window is anticipated to close 60 days from posting or sooner if filled or closed.
The Clinical Document Management Specialist supports clinical trials by processing paper and electronic essential study documents against pre-specified quality criteria, including filing, routing, and coordination of documents to ensure compliance with applicable SOPs and regulatory guidelines.
Essential Functions
- Assist with setup, organization, maintenance, and close-out of study TMF/eTMF.
- Maintain and update the Company’s TMF Plan and TMF index (indexing, tracking, and filing paper and electronic clinical trial documents).
- Maintain the study TMF filing records system.
- Collaborate with Clinical Study teams to guide proper submission and/or filing of clinical study documents.
- Perform and oversee review of documents filed in the TMF/eTMF per SOPs, processes, procedures, and work instructions.
- Prepare, handle, distribute, file, and archive clinical documentation and reports per standard procedures.
- Collaborate on review and improvement of SOPs and departmental policies related to TMF maintenance and archiving.
- Perform regularly scheduled QC of TMF/eTMF per the TMF Plan by monitoring completeness and quality.
- Support internal audits and Regulatory Agency inspections by retrieving documents and providing reports.
- Perform ad-hoc/cross-functional duties and/or projects as assigned.
Education & Experience
- Bachelor’s degree with 1+ years of clinical operations experience in pharma/biotech/CRO required; or
- High School diploma with 4+ years of clinical operations experience in pharma/biotech/CRO required.
- Trial Master File experience preferred.
Knowledge, Skills, & Abilities
- Knowledge of ICH and GCP guidelines.
- Knowledge of clinical trial documents preferred.
- Proficiency in MS Word, Excel, PowerPoint, Outlook.
- Independent and flexible; able to self-direct, adapt to changing priorities, and meet tight deadlines.
- Understand and follow job-specific systems/processes defined by Company SOPs; notify supervisor/manager if unclear.
- Strong communication skills and customer focus; ability to interact cross-functionally.
- Maintain corporate confidentiality; dependability and timeliness.
- Critical thinking, strong attention to detail, document organization, prioritization, scheduling, and meeting deadlines.
Working Environment
- On-site in El Segundo, CA or Remote.
- Monday–Friday within standard business hours (flexibility with manager approval).
- On-call during audits.
Benefits
- Discretionary bonus and equity award.
- Medical, Dental and Vision plan options; health and financial wellness programs; EAP; life/AD&D; short-term and long-term disability; healthcare and dependent care FSAs; 401(k) match; 529 education savings; PTO (11 holidays; unlimited PTO for exempt employees; non-exempt vacation/health pay/personal/cultural days).
Application Instructions
- The application window is anticipated to close 60 days from posting or sooner if filled or closed.