Clinical Data Quality System Testing Expert

Objective /

Purpose:

• Create and execute detailed test plans and UAT scripts in Excel and /or ALM testing system based on business requirements and technical specifications to verify study/library functionality in Veeva CDMS and/or Rave EDC system and adherence to standards.

• Drive study database user acceptance testing activities and ensure the quality of the study build in the EDC system.

• Ensure accurate delivery of study build with quality deliverables per specification. Participate in the development, maintenance and training rendered on activities around study build and best practices used by business.

• Lead UAT activities for studies and libraries in EDC system, including inbound integrations with an Agile Approach according to applicable SOPs (standard operating procedures) and processes.

• Develop UAT documentation such as Test Plans, UAT Scripts, UAT Summary Report etc.

• Create and execute standardized test scripts for EDC components, inbound integrations, and data listings.

• Record and document test results and compare to expected results. Detect software and specifications failures, so that defects may be discovered and corrected.

• Communicate actively with management and clinical teams about testing progress and challenges.

• Collaborate with cross-functional teams and vendors to ensure integration accuracy.

• Demonstrate strong understanding of electronic data capture and clinical data management systems, clinical databases, data flow, and related infrastructure, with experience in/around EDC systems such as Veeva CDMS and Rave, Veeva CDB, Elluminate® Data Central, EHR, eCOA, IRT, RTSM, TSDV, DMR and adjacent systems.

Accountabilities:

Test Plan and Script Execution:

• Create and execute detailed test plans and User Acceptance Testing (UAT) scripts, ensuring alignment with business requirements and technical specifications.

• Validate study/library functionality within EDC systems and confirm adherence to established standards.
Testing Strategy Development:

• Develop and enhance testing strategies for EDC system study/library builds and integrations  UAT Documentation Development:

• Develop comprehensive UAT documentation, including Test Plans, UAT Scripts, and UAT Summary Reports.  Standardized Test Script Creation:

• Develop and execute standardized test scripts for EDC components, inbound integrations, and data listings.
Testing Results Analysis:

• Record and document test results, comparing them to expected outcomes.

• Identify software and specification failures for timely defect resolution.  Communication and Reporting:

• Actively communicate with management and clinical teams about testing progress, challenges, and outcomes.  Support for Special Projects:

• Assist in special projects and automated testing initiatives, including the identification of tools for manual UAT script automation.

Cross-functional Collaboration:

• Work closely with cross-functional teams and vendors to ensure accuracy and efficiency in system integrations.  Expertise in Clinical Data Systems:

• Demonstrate in-depth knowledge of electronic data capture, clinical data management systems, and related infrastructure.

• Utilize experience with various EDC systems (e.g., Veeva CDMS, Rave) and related clinical research technologies (e.g., eCOA, IRT, RTSM).
Core Elements Related to this Role:

• Thorough knowledge and understanding of test case development processes, focused on clinical data with a strong knowledge of clinical study design in EDC and an understanding of clinical data management operations.

• Proven track record in development and management of test documentation including Test Plans, Test Scripts and Test Summary reports and in-depth knowledge of study design through submission.
Technical/Functional…