Clinical Database Programmer

Clinical Database Programmer

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Clinical Database Programmer

Location: Franklin Lakes, NJ

Duration: 12 months
The Clinical Database Programmer will lead the development and maintenance of database builds in support of clinical studies. You will build study databases including development of database specifications/definitions, programming of CRF layouts, programming of validation and derivation procedures, and programming of various reports to support the data review process. You will troubleshoot technical issues as required for staff regarding specific database issues and will contributes to the continual process development within the data management group and helps define best practices.
Essential Job Functions:

• Develops database design specifications/definitions in consultation with data management, statistics and programming.
• Designs and creates clinical databases to enable data review/validation of the study data by Data Managers, and a comprehensive and efficient analysis by Statistics and SAS Programming.
• Programs and tests database configurations (edit checks, derivations, form/field dynamics, etc.).
• Programs and tests reports using SQL/SAS to identify inconsistencies and support data review efforts.
• Performs pre-processing and loading of non-CRF data files.
• Contributes to solutions for routine technical problems and liaises with IT as appropriate to resolve issues.
• Identify and implement solutions to data management issues and concerns that arise during the conduct of the study.
• Identifies and understands the need for standardization and takes initiative to help improve departmental efficiency.
• Establishes and maintains productive working relationships with all other functional areas that contribute to the execution of clinical studies.
• Contributes to the development of Departmental SOPs, Business Guidance and/or Standards/Templates to define best practice and promote consistency.
• Maintains all required study documentation.

Required Qualifications:

• Proficient in Oracle SQL programming
• Understanding of relational databases.
• Experience with development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission.
• Ability to work independently with minimal supervision and manage multiple deliverables concurrently.
• Ability to ensure clinical database programming work is completed in a consistent manner and validated according to department practices.
• Excellent interpersonal skills, strong written and verbal communication skills.
• Working knowledge of clinical development.
• Working understanding of clinical trial principles and technical implications.
• Ability to interact effectively within and across team environment.
• Ability to travel up to 10% of the time