Senior Clinical Data Manager

Location: Van Buren Point

Company Overview Immunity Bio  is a vertically integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response.

The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.

Why Immunity Bio?
• Immunity Bio 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 Senior 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.

Essential Functions 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 database manager for the study specific clinical team, including compilation of edit checks.

Develop database requirements for use by EDC vendors. Serve as 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 PlanCRF Completion Guidelines Coding Guidelines Annotated CRFsEdit 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 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 into data management…