Clinical Trials Manager
ImmunityBio, Inc.
5 hours ago
Remote friendly (California, United States)
United States
Clinical Research and Development
Position Summary
The Clinical Trails Manager is responsible for managing the activities of several clinical studies, including assisting in the development of study-related documents, study site management, and patient data monitoring. Provides daily guidance to clinical sites on protocol interpretation and protocol safety compliance.
Responsibilities
- Assist in the development and management of company-sponsored clinical trials
- Assist in reviewing completed assignments by members of the clinical development group
- Assist in development and management of revisions to study-related documents (e.g., informed consent, laboratory manual, pharmacy manual, CRFs, and other study execution tools)
- Support site recruitment, site initiation, site payments, and site close-out
- Oversee training of new clinical site staff and training for protocol amendments
- Liaise with the regulatory department to collect updated regulatory documents as needed
- Provide daily guidance to clinical sites on protocol interpretation and protocol safety compliance
- Assist in training clinical development group staff
- Prepare and update clinical trial updates for the Clinical Development team
- Lead/moderate DSMB teleconferences; conduct monthly PI and Study Coordinator teleconferences
- Support summarizing and maintaining patient treatment, response, and survival data for active studies
Qualifications
- Bachelor’s degree in biological science with 5+ years of relevant clinical research experience (required)
Skills/Abilities
- Proficiency in MS Word, Excel, PowerPoint, Outlook
- Excellent written/oral communication; strong organizational and multi-tasking skills
- Understanding of job-specific systems/processes per company SOPs and adherence to SOP requirements; escalate unclear/ambiguous requirements
- Maintain corporate confidentiality at all times
Benefits
- Discretionary bonus and equity award
- Medical, dental, and vision plan options
- Employer Assistance Program (EAP)
- Company paid and voluntary life/AD&D; short-term and long-term disability
- Flexible Spending Accounts (healthcare and dependent care)
- 401(k) with company match
- 529 education savings program
- Paid Time Off (PTO) includes 11 holidays; exempt: unlimited PTO; non-exempt: 10 vacation days, 56 hours health pay, 2 personal days, 1 cultural day
Application Instructions
- Application window anticipated to close 60 days from posting or sooner if filled/closed.
The Clinical Trails Manager is responsible for managing the activities of several clinical studies, including assisting in the development of study-related documents, study site management, and patient data monitoring. Provides daily guidance to clinical sites on protocol interpretation and protocol safety compliance.
Responsibilities
- Assist in the development and management of company-sponsored clinical trials
- Assist in reviewing completed assignments by members of the clinical development group
- Assist in development and management of revisions to study-related documents (e.g., informed consent, laboratory manual, pharmacy manual, CRFs, and other study execution tools)
- Support site recruitment, site initiation, site payments, and site close-out
- Oversee training of new clinical site staff and training for protocol amendments
- Liaise with the regulatory department to collect updated regulatory documents as needed
- Provide daily guidance to clinical sites on protocol interpretation and protocol safety compliance
- Assist in training clinical development group staff
- Prepare and update clinical trial updates for the Clinical Development team
- Lead/moderate DSMB teleconferences; conduct monthly PI and Study Coordinator teleconferences
- Support summarizing and maintaining patient treatment, response, and survival data for active studies
Qualifications
- Bachelor’s degree in biological science with 5+ years of relevant clinical research experience (required)
Skills/Abilities
- Proficiency in MS Word, Excel, PowerPoint, Outlook
- Excellent written/oral communication; strong organizational and multi-tasking skills
- Understanding of job-specific systems/processes per company SOPs and adherence to SOP requirements; escalate unclear/ambiguous requirements
- Maintain corporate confidentiality at all times
Benefits
- Discretionary bonus and equity award
- Medical, dental, and vision plan options
- Employer Assistance Program (EAP)
- Company paid and voluntary life/AD&D; short-term and long-term disability
- Flexible Spending Accounts (healthcare and dependent care)
- 401(k) with company match
- 529 education savings program
- Paid Time Off (PTO) includes 11 holidays; exempt: unlimited PTO; non-exempt: 10 vacation days, 56 hours health pay, 2 personal days, 1 cultural day
Application Instructions
- Application window anticipated to close 60 days from posting or sooner if filled/closed.