Software-Tester Lab Data Mgmt 1

Job Overview Intermediate and comprehensive technical expertise in team environment. Under general supervision, assists in authoring and performs execution of test cases for Clinical Trial Databases in Lab Data Management (LDM) systems, to ensure that that clinical trial databases configuration meets the defined requirements and will operate as expected when released into a production environment. Ensures that software defects or issues are documented completely and in a timely fashion to support status reporting and decision making performed by management and project stakeholders. CV must be sent in English Essential Functions Ensure that databases and database extraction processes are documented in accordance with SOPs and reported in a timely fashion to support operations Provide technical expertise to internal and external clients Program, test, and document databases in accordance with programming standards and validation procedures Independently bring solutions to the Project Development and Validation (PDV) teams May assist IT in evaluating and / or developing and implementing new technologies. Meet assigned milestones and interact with the project team to organize timelines, responsibilities and deliverables Develop and maintain good communications and working relationships with teams and external clients May assist in developing, revising, and maintaining core operating procedures and working instructions with PDV management. Testing Plan and coordinate the testing plan and test cases of laboratory data systems, data extractions or business reports Correctly uses and supports the maintenance of test data to support test case execution and libraries of reusable test data sets Reviews specifications and requirements for testability and verify traceability of testing to requirements Assists in internal peer reviews of test cases from other testers prior to execution as required to ensure issues / errors with the test scripts are identified and resolved. Understand and comply with core standard operating procedures and working instructions Multiple communication styles and skill to effectively broker audience specific (peers, senior team members, internal / external customers) business and interpersonal relationships that leads to positive outcomes and successful business results Perform other duties as directed by the functional manager. Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice Qualifications Bachelor's Degree Computer / life science or related field Req 1-5 years' relevant work experience. Equivalent combination of education, training and experience. Solid understanding of laboratory data management systems and the clinical drug development process. Strong customer-focus perspective with skill to guide customer communications and customer management. Self-driven with keen attention to detail to anticipate, address and / or elevate issues, with aptitude to embrace and be conduit for change. Project and task management capabilities to meet / exceed deliverables. Effective problem-solving skills as well as ability to proactively identifying process improvements which reduce operational costs and maintain quality. Quality conscious with high degree of ethics and integrity carrying out duties in accordance with laws, regulatory standards, and with company policies and procedures. Demonstrated ability to manage multiple projects and tasks simultaneously. Good understanding of medical, clinical research, and Lab Data Management process and terminology (preferred) Knowledge on various regulatory requirements such as FDA 21CFRPart11, ICH, ISO HL7, and GLP (Good Laboratory Practices) (preferred) #J-18808-Ljbffr