Clinical Trials Manager
ImmunityBio, Inc.
Full-time
Remote friendly (El Segundo, CA)
United States
Clinical Research and Development
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Role Summary
The Clinical Trials 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. The role will provide guidance to clinical sites on a daily basis including 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 the development and management of revisions to study-related documents such as the informed consent, laboratory manual, pharmacy manual, case report forms (CRFs) and other study execution tools
- Provide support in site recruitment, site initiation, site payments and site close-out
- Help to oversee the training of new clinical site staff or site training for protocol amendments
- Liaise with the regulatory department for the collection of updated regulatory documents as needed
- Help to provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance
- Assist in the training of clinical development group staff
- Prepare and update clinical trial updates for Clinical Development team
- Lead/moderate DSMB teleconferences, monthly PI and Study Coordinator teleconferences
- Provide support for summarizing and maintaining patient treatment, response and survival data for active studies
- Performs other duties as assigned
Qualifications
- Bachelor’s degree in biological science with 5+ years of relevant experience in clinical research required
Skills
- Proficiency in MS Word, Excel, PowerPoint, Outlook
- Excellent written/oral communication skills as well as strong organizational and multi-tasking skills
- Understand the job-specific system and processes as defined by the company’s SOPs and adhere to the requirements listed in those documents
- Maintain corporate confidentiality at all times
Education
- Bachelor’s degree in biological science
Additional Requirements
- This position works on site in El Segundo, CA or remotely depending on the geographic location of the candidate
- Regular work schedule is Monday – Friday, within standard business hours; flexibility with manager approval
- Travel may be required up to approximately 20%
- Lift and carry materials weighing up to 20 pounds