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Senior Business Analyst - Clinical and Regulatory Systems

Employer
ImmunityBio, Inc
Location
El Segundo, CA
Start date
Nov 11, 2022

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Job Details

ImmunityBio, Inc. is a late-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious disease. The company’s immunotherapy platform is designed to activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term “immunological memory.”

POSITION SUMMARY

The Senior Business Analyst manages, administers, and supports multiple business applications across the enterprise with a primary focus on our Veeva implementation. This role requires extensive experience supporting all types of applications with significant experience supporting the Veeva stack.

ESSENTIAL FUNCTIONS

  • Act as a delivery and support expert for the Veeva Stack, which includes but is not limited to, eTMF, Clinical, Payments, RIM Submissions and Submissions Archive.
  • Design, document, build, test and deploy enhancements to Veeva custom objects, page layouts, workflows, alerts, reports and dashboards within Veeva, ensuring they are accurate and meet user requirements.
  • Perform bulk data updates ensuring Quality of data, using data loader.
  • Consult fellow staff and business owners, regarding implications to the business and to the current Veeva Org. Communicate effectively with key stakeholders when making changes to the system.
  • Assist with development of SOPs, Work Instructions and training materials
  • Manage interfaces between systems
  • Participate in user requirement sessions and document user requirements to address changing business needs.
  • Maintain systems in a validated state at all times
  • Assist with Change Management and release processes for validated applications
  • Facilitate resolution of Tier 2 and Tier 3 application issues for BRMs
  • Assist with Governance activities
  • Builds strong trusted relationships with BRMS
  • Maintain a holistic view of all business processes and users in the system to understand cross-functional impacts with regards to configuration, process, workflow and reporting.

EDUCATION & EXPERIENCE

  • 5 to 10 years of experience as an IT Business Analyst / Engineer or equivalent
  • Required minimum of 3 years of experience supporting multiple modules of the Veeva stack
  • Experience Supporting Veeva Clinical Vault eTMF, CTMS and Payments as a Business Administrator or a system Administrator
  • Exceptional analytical and conceptual thinking skills
  • Understanding of and experience with different types of clinical pharmaceutical data
  • Experience supporting applications in a GxP environment
  • Knowledge of 21CFR11 and ICH preferred

KNOWLEDGE, SKILLS, & ABILITIES

  • Ability to influence stakeholders and work closely with Business Functional Teams to develop consensus around optimum solutions
  • Veeva white belt or higher certification preferred
  • Clear and proactive communication skills
  • Understanding of Gxp regulations as it pertains to Clinical and Regulatory systems
  • Understanding of Veeva security model for Clinical and Regulatory Applications
  • Proven ability to create reports and dashboards in Veeva.
  • Understanding of DIA reference Model for eTMF
  • Excellent communication and documentation skills, including technical writing
  • Experience creating detailed assessments and giving presentations
  • Excellent planning, organization, and time management skills
  • Experience leading and supporting successful projects
  • Experience with strategic business process modeling and traceability

*All hires are based upon completion and passage of a background check

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.

Company

ImmunityBio, Inc. is a late-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious disease. The company’s immunotherapy platform is designed to activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term “immunological memory.”

Stock Symbol: IBRX

Find Us
Website
Phone
844-696-5235
Location
9920 Jefferson Blvd.
Culver City
CA
90232
United States
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