Senior Clinical Trials Manager
About The Position
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. 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. This position is responsible for managing the activities of several global clinical studies including assisting in the development of study-related documents, study site management, and patient data monitoring. Provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance.
Requirements
- Bachelor’s degree with 7+ years of relevant experience in clinical research required
- 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.
Responsibilities
- Assist Clinical Project Manager in the development and management of company-sponsored global clinical trials
- Lead in reviewing completed assignments by members of the clinical development group
- Lead/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 in-house team to ensure 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.
- Lead/Assist in the training of clinical development group staff.
- Assist CPM to prepare and update clinical trial updates for Clinical Development team
- Provide support for summarizing and maintaining patient treatment, response and survival data for active studies.
- Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates.
- Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.
Benefits
- Medical, Dental and Vision Plan Options
- Health and Financial Wellness Programs
- Employer Assistance Program (EAP)
- Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
- Healthcare and Dependent Care Flexible Spending Accounts
- 401(k) Retirement Plan with Company Match
- 529 Education Savings Program
- Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
- Paid Time Off (PTO) includes: 11 Holidays
- Exempt Employees are eligible for Unlimited PTO
- Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
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What This Job Offers
Job Type
Full-time
Career Level
Senior
