Clinical Document Management Specialist

2 months ago

Mariposa, United States ImmunityBio Full time

Company Overview
ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease.

Why ImmunityBio?
* 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.
* Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.
* Work with a collaborative team with the ability to work across different areas of the company.
* Ability to join a growing company with professional development opportunities.

Position Summary

The Clinical Document Management Specialist supports clinical trials by processing both paper and electronic essential study documents against pre-specified quality criteria to include filing, routing, and coordination of documents to ensure compliance with applicable Standard Operating Procedures (SOPs) and regulatory guidelines.

Essential Functions

  • Provides operational and administrative guidance for the study TMF/eTMF by assisting with the setup, organization, maintenance, and close-out of study specific TMF/eTMF.
  • Maintains and updates of Company's standard TMF Plan and TMF index, including indexing, tracking, and filing of paper and electronic clinical trial documents.
  • Maintains the study TMF filing records system.
  • Collaborates with the Clinical Study teams to guide proper submission and/or filing of clinical study related documents for completion of required tasks to meet departmental and project goals.
  • Performs and oversees a review of documents filed in the TMF/eTMF as outlined by SOPs, company processes, procedures, and work instructions.
  • Oversight in preparing, handling, distributing, filing and archiving of clinical documentation and reports per standard procedures.
  • Collaborates in the review and improvement of SOPs and Departmental Policies and Procedures as it relates to TMF maintenance and archiving.
  • Performs the regularly scheduled QC of the overall TMF/eTMF per the TMF Plan by monitoring completeness and quality of the TMF.
  • Maintains internal audits and Regulatory Agency inspections by retrieving documents and providing reports.
  • Performs other duties as assigned.

Education & Experience

  • Bachelor's degree with 1+ years of clinical operations experience in pharma, biotech or CRO; or High School diploma with 4+ years of clinical operations experience in pharma, biotech or CRO
  • Trial Master File experience preferred

Knowledge, Skills, & Abilities

  • Demonstrated knowledge of ICH and GCP guidelines
  • Demonstrated knowledge of clinical trial documents is preferred
  • Proficiency in MS Word, Excel, PowerPoint, Outlook
  • Must be independent, flexible, and work well in a team environment, but also be self-directed and adapt to changing priorities and complete tasks under tight deadlines.
  • Understand job-specific systems and processes as defined by Company SOPs and adhere to requirements listed in those documents. If any procedure or process requirements are unclear or ambiguous, it is the responsibility of the employee to notify his/her supervisor or manager
  • Solid communication skills and strong customer focus with the ability to interact in a cross functional organization
  • Maintain corporate confidentiality at all times Dependability and timeliness
  • Requires Critical Thinking skills, ability to lead co-workers, strong attention to detail, document organization skills, establishing priorities, scheduling, and meeting deadlines

Working Environment / Physical Environment

  • This position works on-site in El Segundo, CA or Remote
  • Requires being at a computer for several hours at a time
  • On-call during audits

This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location.

$28.50 (entry-level qualifications) to $36.00 (highly experienced) hourly

The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.

ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: 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 * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.

At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

ImmunityBio is a mandatory vaccination employer for COVID-19 and its variants. The Company requires that its employees be fully vaccinated as of their start date. If you require a medical or religious accommodation we will engage in the interactive process with you. Proof of vaccination will be required prior to start. If we make you an offer and you are not yet vaccinated, we will accommodate a delay in start date. ImmunityBio may also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed.

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