Clinical Trials Manager

ImmunityBio, Inc.El Segundo, CA
83d$124,650 - $138,500

About The Position

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. The role will provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance.

Requirements

  • Bachelor’s degree in biological science
  • 5+ years of relevant experience in clinical research
  • Proficiency in MS Word, Excel, PowerPoint, Outlook
  • Excellent written/oral communication skills
  • 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

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

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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