Clinical Database Programmer
ImmunityBio, Inc.•El Segundo, CA
43d•$108,500 - $126,500•Remote
About The Position
The Clinical Database Programmer will assist in designing, programming, and testing Electronic Data Capture (EDC) databases for the purpose of conducting clinical studies. The role works with Clinical Study Teams to assist in developing EDC databases in adherence to departmental Standard Operating Procedures (SOPs).
Requirements
- Bachelor’s Degree in a science-related field is required.
- 3+ years of clinical database programming experience is required.
- Experience with EDC database development is required.
- Proficiency in various programming languages, including JavaScript and SAS.
- Knowledge of CDISC/SDTM standards.
- Working knowledge of Good Clinical Practices and regulatory requirements including FDA regulations 21 CFR Part 11.
- Proficiency in computer skills across multiple applications.
- Strong English verbal and written communication skills; good organizational and interpersonal skills.
Nice To Haves
- Experience working in the pharmaceutical/Biotechnology industry is preferred.
- Knowledge of TrialMaster and/or Veeva Vault CDMS EDC systems preferred.
- Experience with clinical coding dictionaries including MedDRA and WHODrug.
Responsibilities
- Assist in EDC database development in consultation with Clinical Data Managers, Statistical Programmers, Biostatisticians, and Clinical Trial Managers.
- Assist in design, program, and test EDC databases including eCRFs, dictionaries, data validation checks, database functions (including new), and standard and custom database reports.
- Maintain a global library according to current (CDISC/SDTM) and new standards.
- Assist with EDC database User Acceptance Testing.
- Assist with the Development and maintenance of EDC database documentation.
- Provide EDC technical support to facilitate study timelines and deliverables.
- Conduct training on EDC database usage to support internal and external users.
- In conjunction with the Senior Database Programmer, coordinate EDC database software validation efforts.
- Maintain Coding Dictionary updates/version control within the application
- Serve as a resource for Clinical Data Management SOP development and best practices in an effort to improve quality and streamline EDC database build and data cleaning efforts.
- Serve as point of contact for Clinical Database Programmers inclusive of training and mentoring as needed.
- 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.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
501-1,000 employees
