UAT + Veeva EDC Tester

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 (Line) Expertise (Breadth and depth of knowledge, application, and complexity of technical knowledge) Comprehensive understanding of the pharmaceutical industry and clinical development. Functional level expertise of testing and validation of clinical systems. Comprehensive understanding of medical concepts, clinical data flow and systems used in the clinical space. Hands-on experience and knowledge of the various components of EDC system and clinical study life cycle. Good knowledge of clinical systems and tools (e.g. Veeva CDMS, Rave EDC, Veeva CDB, Elluminate) Desirable technical expertise (e.g., Windows NT and UNIX operating systems) and familiarity with common test case management software, familiarity with ALM, UFT, Tosca and Quest. Expertise in the requirements and technology required to support electronic data capture and electronic submissions. Interaction (The span and nature of ones engagement with others when performing ones job, internal and external relationships) Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills. Effectively navigates the changing external and internal environment and leads others through change by creating and Objec