Clinical Trials Manager
ImmunityBio, Inc.
5 months ago
Remote friendly (California, United States)
United States
Clinical Research and Development
Responsibilities
- Assist in the development and management of company-sponsored clinical trials.
- Assist in reviewing completed assignments by the clinical development group.
- Assist in developing/maintaining revisions to study documents (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 regulatory for 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; run monthly PI and Study Coordinator teleconferences.
- Summarize and maintain patient treatment, response, and survival data for active studies.
Qualifications
- Bachelor’s degree in biological science; 5+ years of relevant clinical research experience required.
Skills/Abilities
- Proficiency in MS Word, Excel, PowerPoint, Outlook.
- Excellent written/oral communication; strong organizational and multitasking skills.
- Understand and follow SOP-defined processes; maintain corporate confidentiality.
Benefits
- Medical, dental, and vision plan options; health and financial wellness programs; EAP; life/AD&D; short- and long-term disability; healthcare/dependent care FSAs; 401(k) match; 529; PTO; and other listed perks.
Application instructions
- Application window: closes in 60 days from posting or sooner if filled/closed.
- Assist in the development and management of company-sponsored clinical trials.
- Assist in reviewing completed assignments by the clinical development group.
- Assist in developing/maintaining revisions to study documents (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 regulatory for 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; run monthly PI and Study Coordinator teleconferences.
- Summarize and maintain patient treatment, response, and survival data for active studies.
Qualifications
- Bachelor’s degree in biological science; 5+ years of relevant clinical research experience required.
Skills/Abilities
- Proficiency in MS Word, Excel, PowerPoint, Outlook.
- Excellent written/oral communication; strong organizational and multitasking skills.
- Understand and follow SOP-defined processes; maintain corporate confidentiality.
Benefits
- Medical, dental, and vision plan options; health and financial wellness programs; EAP; life/AD&D; short- and long-term disability; healthcare/dependent care FSAs; 401(k) match; 529; PTO; and other listed perks.
Application instructions
- Application window: closes in 60 days from posting or sooner if filled/closed.