Clinical Data Manager

Benefits

Additional Information

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company 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. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? - ImmunityBio 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 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 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 files 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 into 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. Adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates. Perform ad-hoc and cross-functional projects assigned to support business needs and provide developmental opportunities. Education & Experience Bachelor's Degree in a science-related field with 4+ years of experience; or High school diploma with 8+ year of relevant experience. 4+ years of clinical data management experience required. Experience working with EDC clinical databases required. Veeva Vault CDMS and TrialMaster experience preferred. MedDRA and WHO Drug coding experience preferred. Knowledge, Skills, & Abilities Working knowledge of clinical research, Good Clinical Practices, and regulatory requirements Knowledge of CDISC/STDM standards. Excellent English verbal and written communication skills; good organizational and interpersonal skills. Working Environment / Physical Environment This position works onsite or remote based on the candidate's location Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval. Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer Lift and carry materials weighing up to 20 pounds This position is eligible for a discret