
Clinical Data Specialist
2 days ago
Clinical Data Tester Role Overview
This role involves performing User Acceptance Testing (UAT) for CRF screens, database edit checks, and reports/listings.
- We are seeking a highly skilled Clinical Data SME to join our team in this clinical data testing and validation position.
- The ideal candidate will possess a Bachelor's degree in Life Sciences or Computer Science and have at least 8 years of experience in clinical data testing.
- Key responsibilities include:
- Testing clinical study setup configurations including protocol parameters, visit schedules, and form designs.
- Validating external data acquisition (Lab, ECG, PK/PD) and ensuring accurate processing.
- Collaborating with Clinical Data Scientists and Study Data Managers to understand study scope and expectations.
- Reviewing edit check specifications; writing and executing UAT scripts.
- Conducting Quality Control (QC) on metadata listings and peer reviewing programming checks.
- Supporting automation tool validation and standardizing test scripts.
A solid understanding of SDLC, validation methodology, and document management is required for this position.
Required Skills and Qualifications
To be successful in this role, you will need the following skills and qualifications:
- Bachelor's degree in Life Sciences or Computer Science.
- At least 8 years of experience in clinical data testing and validation.
- Strong experience with clinical study setup and CDMS platforms and CTMS.
- Knowledge of GxP/GcP and internal SOPs.
Benefits
This role offers a range of benefits, including:
- Opportunities for professional growth and development.
- A collaborative and dynamic work environment.
- Competitive compensation package.
Others
As a Clinical Data SME, you will have the opportunity to work on a variety of projects and contribute to the development of clinical data testing methodologies.
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