[Hiring] Clinical Trials Manager @ImmunityBio, Inc.

Role Description

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.

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:
  • Informed consent
  • Laboratory manual
  • Pharmacy manual
  • Case report forms (CRFs)
  • 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.
• Perform other duties as assigned.

Qualifications

• Bachelor’s degree in biological science with 5+ years of relevant experience in clinical research required.

Requirements

• 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.

Working Environment / Physical Environment

• This position works on site or remotely depending on the geographic location of the candidate as noted in the offer letter.
• Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval.
• This position will be exposed to an in-lab environment.
• This position may travel approximately 20% of the time.
• Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
• Lift and carry materials weighing up to 20 pounds.

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