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 one’s engagement with others when performing one’s 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 inspiring and engaging workplace.
•Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise.
•Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner.
•Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions.
•Proven track record in identifying and implementing organization-wide initiatives, standards, and processes.
Innovation (The required level of scientific knowledge, knowledge sharing, innovation and risk taking)
•Forward thinking with the ability to recommend, influence and implement organizational change and continuous improvement.
•Comfortable challenging the status quo and bringing forward innovative solutions.
•Ability to take risks implementing innovative solutions, accelerating time to market.
•Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.
•Role models respect and inclusion, creating a culture that fosters innovation.
•Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenges the status quo.
Complexity (Products managed, mix of businesses, internal and/or external business environment, cultural considerations)
•Ability to work in a global ecosystem (internal and external) with a medium to high degree of complexity.
•Ability to see and understand broader, enterprise level perspective as well as from collection through submission perspective.
Education & Competencies (Technical and Behavioral):
•BS/BA or MS in a Life Science, Computer Science, IT, Engineering, or related field or analytical area with ~10 years of experience in a CRO/pharmaceutical environment with a proven and consistent record of proactive management and innovation.
•Experience with EDC and clinical data management systems.
•Familiarity with clinical research technologies (e.g., eCOA, IRT, RTSM).
•Experience in software testing and quality assurance.
•Proficiency in Agile methodologies and adherence to SOPs.
•Understanding of clinical data management processes and regulations.
•Strong problem-solving skills and attention to detail.
•Previous experience leading a medium to large organization and influencing senior-level management and key stakeholders is a plus.
•Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables.
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