Senior Clinical Trials Manager

ImmunityBio, Inc.El Segundo, CA
1dHybrid

About The Position

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.
  • 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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