Job Description

Senior Clinical Data Manager

ImmunityBio 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.

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 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 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 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.
• Perform other special projects and duties as requested.

Education & Experience

• Bachelor's Degree in a science-related field with 5+ years of experience required; or
• High school diploma with 9+ years of relevant experience required
• 5+ 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/guidelines.
• Knowledge of CDISC/STDM standards.
• Excellent verbal and written communication skills; good organizational and interpersonal Skills

Working Environment / Physical Environment

• This position works onsite in Dunkirk, NY
• 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 discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location.

$117,900 (entry-level qualifications) to $131,000 (highly experienced) annually

The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.

ImmunityBio uses artificial intelligence (AI) tools to assist with sourcing and identifying potential candidates for open positions. These tools help us reach qualified applicants and improve the efficiency of our recruitment outreach. No preference is given to applicants sourced or identified by AI tools.

Important: AI is not used to screen, evaluate, rank, assess, or make hiring decisions about applicants. All applications are reviewed by human recruiters and hiring managers. Hiring decisions are made solely by ImmunityBio personnel without automated decision-making.

We are committed to equal employment opportunity and ensure that all candidates are assessed based on their qualifications, skills, and experience through human review.

ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options • Health and Financial Wellness Programs • Employer Assistance Program (EAP) • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability • Healthcare and Dependent Care Flexible Spending Accounts • 401(k) Retirement Plan with Company Match • 529 Education Savings Program • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks • Paid Time Off (PTO) includes: 11 Holidays • Exempt Employees are eligible for Unlimited PTO • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day • We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.

At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

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