Roles & Responsibilities
- 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.
Experience Required
- 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
- Working understanding of clinical trial principles and technical implications.
Skills & Certifications
- Excellent interpersonal skills, strong written and verbal communication skills.
- Working knowledge of clinical development.
- Ability to ensure clinical database programming work is completed in a consistent manner and validated according to department practices.
- Ability to travel up to 10% of the time
- Ability to interact effectively within and across team environment.
Eligibilities & qualifications
- Proficient in Oracle SQL programming
- Bachelors Degree
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