Clinical Database Programmer

Role Summary

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).

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.

Qualifications

• Required: Bachelor‚Äôs Degree in a science-related field.
• Required: 3+ years of clinical database programming experience.
• Required: Experience with EDC database development.
• Preferred: Experience working in the pharmaceutical/biotechnology industry.

Knowledge, Skills, & Abilities

• Proficiency in various programming languages, including JavaScript and SAS.
• Knowledge of CDISC/SDTM standards.
• Knowledge of TrialMaster and/or Veeva Vault CDMS EDC systems (preferred).
• Experience with clinical coding dictionaries including MedDRA and WHODrug.
• 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.

Education

• Bachelor‚Äôs Degree in a science-related field is required.

Additional Requirements

• This position works onsite or remote based on the candidate‚Äôs geographic location.
• Regular work schedule is Monday ‚Äì 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.