Clinical Database Programmer 2

Location : Franklin Lakes, NJ

Duration : 5 Months

Total Hours/week : 40.00

Client: Medical Device Company

Job Category: Technical

Level Of Experience: Senior Level

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

Job Description

• The Clinical Database Programmer will lead the development and maintenance of database builds in support of clinical studies.
• He / she 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.
• The Clinical Database Programmer will troubleshoot technical issues as required for staff regarding specific database issues.
• He / She contributes to the continual process development within the data management group and helps define best practices.

• 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.

• 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