Clinical Data Manager (fully remote)
Company: ImmunityBio, Inc.
Posted on: June 25, 2022
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
- 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
- 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
- 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
- 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!
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
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
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