
Clinical Data Specialist
18 hours ago
Overview:
We are seeking a highly skilled Clinical Data SME Tester to join our team. In this role, you will be responsible for performing User Acceptance Testing (UAT) for Clinical Research Form (CRF) screens, database edit checks, and exception reports/listings.
Responsibilities:
- Bachelor's degree in Life Sciences, Computer Science, or related field required.
- 8+ years of experience in clinical data testing and validation.
- Test clinical study setup configurations including protocol parameters, visit schedules, and form designs.
- Validate external data acquisition (Lab, ECG, PK/PD) and ensure accurate processing.
- Collaborate with Clinical Data Scientists and Study Data Managers to understand study scope and expectations.
- Strong experience with clinical study setup and Clinical Data Management Systems (CDMS) platforms and Clinical Trial Management Systems (CTMS).
- Review edit check specifications; write and execute UAT scripts.
- Conduct Quality Control (QC) on metadata listings and peer review of programming checks.
- Support automation tool validation and standardization of test scripts.
- Ensure consistent use of clinical data standards across programs and repositories.
- Work with CDMS platforms (e.g., Medidata Rave, Oracle InForm) to validate database builds and data flows.
- Ensure compliance with Good eXperimental Practices (GxP) and internal Standard Operating Procedures (SOPs).
- Document and share study-related testing deliverables and lessons learned.
Benefits:
This role offers a unique opportunity to work with a talented team of professionals who are passionate about delivering high-quality results. You will have the chance to develop your skills and expertise in clinical data testing and validation, and contribute to the success of our organization.
Others:
We are an equal opportunities employer and welcome applications from diverse candidates. If you are a motivated and detail-oriented individual with a passion for clinical data testing and validation, we encourage you to apply for this exciting opportunity.
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