Clinical Data Manager (fully remote)

Company: ImmunityBio, Inc.
Location: Denver
Posted on: June 25, 2022

Job Description:

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."

ImmunityBio, Inc. is looking for a remote Clinical Data Manager (home-office based or hybrid).

Who We Are

ImmunityBio, Inc. is 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.

What You'll Be Doing

A Clinical Data Manager is an expert in clinical data management with demonstrated capability in building and maintaining clinical trial databases. They contribute to process improvements and initiatives within the Biometrics department as well as mentor and train junior staff members as applicable.

You will be responsible for---

• Create and/or review study-specific electronic or paper Case Report Forms (CRFs) using prior knowledge, protocol-specific information, and departmental standards. Work efficiently to incorporate core clinical team input and produce CRFs in a timely manner.
• Configure, migrate, and test electronic data capture (EDC) databases based on internal procedures, study requirements, and system best practices. Serve as a database manager for the study-specific clinical team, including the compilation of edit checks.
• Develop database requirements for use by EDC vendors. Serve as a study database manager and work with vendors to obtain deliverables in a timely manner.
• Create and/or review study-specific data management and database documentation, which may include:
  • Data Management Plan
  • CRF Completion Guidelines
  • Coding Guidelines
  • Annotated CRFs
  • Edit Check Specifications
  • Attend study-specific team meetings and produce status reports and requested metrics, which may include query information or data trends.
  • Perform data review and query generation/closure.
  • Perform coding of verbatim terms such as adverse events and concomitant medications. Collaborate with medical scientists for coding, consistency, review, and approval. Incorporating coding file into the clinical database.
  • Participate in the development of new processes or revision of existing processes.
  • Train internal colleagues in clinical data management in either informal or formal settings as needed.
  • Train Investigators and/or Study Coordinators at Investigator Meeting on the CRFs, the EDC system, and the CRF completion guidelines as needed.
  • Provide data management expertise and support to the clinical teams using data management best practices.
  • Provide analytical insight on data management strategies and advise the internal team with tactical strategies accordingly.
  • As necessary, provide work direction, guidance, mentoring, influence, and support to junior staff. Train junior staff in more complex clinical data management processes.
    What Skills & Experience You'll Bring To Us
    
    • Bachelor's Degree in Science or related field.
    • 2-5 years of clinical data management experience,;
    • Oncology and RECIST experience strongly preferred
    • Working knowledge of Clinical Research, Good Clinical Practices (GCP), and regulatory requirements/guidelines.
    • Experience working with EDC clinical databases.
    • MedDRA and Who Drug coding experience.
    • Knowledge of CDISC/STDM standards.
    • Excellent English verbal and written communication skills; good organizational and interpersonal skills.
      Want to apply? Get in touch today
      
      Visit us at www.ImmunityBio.com/careers to view any of our current openings and apply today!
      
      Disclaimer
      
      ImmunityBio, Inc. is proud to be an equal opportunity employer. We are committed to fostering an environment where diversity is valued. All qualified applicants will receive consideration for employment based on merit, qualifications and the needs of the business.
      
      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.

Keywords: ImmunityBio, Inc., Denver , Clinical Data Manager (fully remote), Executive , Denver, Colorado