ImmunityBio (formerly NantCell) develops novel combinations of chemo-immune sensitizers, cell therapies, cytokines, vaccines, neoepitopes, and monoclonal antibody immunotherapies to orchestrate the NK and T Cell response for cancer and infectious diseases.

Manager, Data Management 

POSITION SUMMARY

The Manager, Data Management 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 and are expected to manage direct reports.

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 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 clinical database.


• Participate in development of new processes or revision of existing processes.


• Manage day-to-day activities of junior data management staff 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 internal team with tactical strategies accordingly.


• Train junior staff in more complex clinical data management processes.

EDUCATION/EXPERIENCE REQUIREMENTS

• Bachelor’s Degree in a science-related field.


• 6+ years of clinical data management experience.

REQUIRED COMPETENCIES – KNOWLEDGE, SKILLS, ABILITIES

• Working knowledge of the clinical research, Good Clinical Practices, 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.

WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS

• Moderate use of telephone and face-to-face communication requiring accurate perception of speech.


• Moderate use of keyboard requiring repetitive motion of fingers and regular sitting for extended periods of time.


• Minimal travel is required for training and company meetings.