TMF Quality Assurance Manager

1 day ago

Mountain Home, Arkansas, United States Lifelancer Full time

Job Title: TMF Quality Assurance Manager

Location: USA

Contract Type: Full-time

Seniority Level: Mid-Senior level


Company Overview

ImmunityBio is a leading biopharmaceutical company dedicated to developing innovative solutions for patients suffering from cancer and infectious diseases. We're committed to reprogramming the patient's immune system to treat the host, not just the disease.

Our team of experts is working tirelessly to develop cutting-edge therapies and vaccines that harness the power of the human immune system. With a strong focus on quality and excellence, we're driven to make a difference in the lives of patients worldwide.


Salary

The estimated hourly base pay for this position ranges from $28.85 (entry-level qualifications) to $40.00 (highly experienced).


Job Description

The TMF Quality Assurance Manager will oversee the maintenance and control of the Trial Master File (TMF), ensuring compliance with regulatory requirements and industry standards. This includes partnering with Clinical Records Management on TMF deliverables, coordinating and supporting Clinical Operations TMF Quality Control processes, and creating and reporting TMF metrics.

The successful candidate will have excellent organizational and time management skills, be detail-oriented, and possess superb communication skills, both oral and written.


Required Skills and Qualifications
  • Bachelor's degree with 3+ years of relevant Trial Master File experience (or 6+ years relevant clinical research experience)
  • Experience in study start-up, study maintenance, and document quality reviews preferred
  • Relevant experience in clinical trials related roles (i.e., clinical operations and project management)
  • Previous experience with independently managing projects and handling concurrent tasks in a fast-paced environment and delivering results within tight timelines desirable
  • Experience with eTMF maintenance
  • Veeva Vault experience preferred

Benefits

As an employee of ImmunityBio, you'll enjoy a competitive total rewards benefits package, including Medical, Dental, and Vision Plan Options, Health and Financial Wellness Programs, Employer Assistance Program (EAP), Company Paid and Voluntary Life/ADD, 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, Employee Discounts, Rewards, and Perks, Paid Time Off (PTO) includes: 11 Holidays, Exempt Employees eligible for Unlimited PTO, Non-Exempt Employees eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days, and 1 Cultural Day.


Working Environment

This role will work remotely, primarily at a computer most of the day. As a valued member of our team, you'll have the flexibility to work independently as well as in a team environment.

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