
Clinical Trials Manager
ImmunityBio, Inc. (NANTKWEST, Inc.)
DUNKIRK, NYJobSeen todaySeen in employer's feed today
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Job overview
The Clinical Trials Manager manages activities across several clinical studies, including study-document development, site management, and patient-data monitoring. The role guides clinical sites on protocol interpretation and safety compliance, supports site recruitment and training, and coordinates with regulatory teams. It also prepares study updates, leads study-related teleconferences, and maintains patient treatment, response, and survival data.
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Full job description
Company Overview ImmunityBio is a vertically integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company's range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. Why ImmunityBio?* ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.* Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.* Work with a collaborative team with the ability to work across different areas of the company.* Ability to join a growing company with professional development opportunities. Position SummaryThe 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. The role will provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance.Essential Functions * 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.Education & Experience * Bachelor's degree in biological science with 5+ years ofrelevant experience in clinical research requiredKnowledge, Skills, & Abilities * 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. If any of the procedure or process requirements are unclear or ambiguous, it is the responsibility of the employee to notify his/her supervisor or manager. * Maintain corporate confidentiality at all times.Working Environment / Physical Environment * T
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